Cosmetics products are created for application on the body for the purpose of cleansing, beautifying or altering appearance and enhancing attractive features. It is not similar like medicines in addition to it cannot be used to modify the physique function or performance. The cosmetic Industry has witnessed rapid growth over the last couple of decades. Now a day the range of cosmetic and beauty products has widened tremendously. The use of cosmetics has increased exponentially not only among in females but the male population also indulges in their use. A wide range of chemical and natural materials is used in the formulation of cosmetic and toiletry preparations. Cosmetics like creams, gels, face powder, eye makeup, shaving cream, and colognes are used on a daily basis by both women and men. The Indian cosmetic Industry has witnessed rapid growth over the last couple of decades. In that time the range of cosmetic and beauty products in India has widened tremendously. Beauty products manufacturers in India mostly cater to the great demand for cosmetics and toiletries that fall into the low or medium price categories as the greatest demand in India has always been for these economically priced products. Bearing a long glowing heritage of cosmetic and beauty, aesthetic makeup products is being used since olden days and nowadays it appear like a booming economy in India which would be the largest cosmetic consuming country in a next few decades. While the demand of beautifying substances are growing day by day, a large number of local as well as international manufacturers gradually extend their ranges and products in different provinces of India. Industry sources estimate a rapid growth rate of 20% per annum.
Some of the fundamentals of the book are regulation of cosmetic products, the relationship of cosmetic products to drugs, preservation of cosmetics, factors affecting preservation, organisms found in cosmetics, antiperspirants and deodorants, cleansing creams and lotions, baby toiletries, face powder manufacturing process, aerosol cosmetics, shaving preparations: soaps, creams, oils, and lotions, advantages and disadvantages of natural dyes, packaging cosmetic preparations, etc.
The book covers formulae, manufacturing processes of various types of cosmetics like antiperspirants and deodorants, cleaning creams, lotions, emollient creams, baby toiletries, face powder, eye makeup and many more along with testing methods. This book will be great asset to new entrepreneurs, existing units, technocrats and technical institutions.
regulation of cosmetic products
The modern day mass market toiletry
industry began in the US in the early years of the 20th century and
particularly between the two world wars. Whilst the industry record for
safety of its product was good this rapid expansion in consumer
rise to calls for action to pre empt possible problems that could
Consumer pressure and advances in the science of toxicology added to
In the US the Pure Food and Drugs
Act of 1906 enacted
to extend formal federal controls over foods and drugs did not include
cosmetics reportedly as the result of a political compromise. Not until
of the Food Drug and Cosmetic Act in 1938 were cosmetics included in
general prohibitions against manufacturing and marketing adulterated or
misbranded products. The 1938 Act also made it possible for products
unregulated to come under Food and Drug Administration (FDA) control as
if they were intended not only for medicinal and therapeutic purposes
if they were intended to affect the structure or function of the body.
Act has since been amended to control the safety of cosmetic colors.
Regulations under both the FDC Act and the Fair Packaging and Labeling
(FDCA) administered by FDA restricted or prohibited cosmetic
to be unsafe and required extensive informative labeling of cosmetic
Other national and regional
governments have likewise
sought to govern cosmetic products. In Japan cosmetics are included in
Pharmaceutical Affairs Law administered by the Ministry of Health and
The law requires that cosmetic manufacturers and importers be licensed
each cosmetic placed on the Japanese market either be in conformance
monographs that make up the Comprehensive Licensing Standards of
have obtained direct individual approval from the Ministry.
In Europe prior to 1976 there was
control of cosmetics and local legislation varied widely. Some
Germany already had a highly developed regulatory system whilst other
almost solely on rather antiquated rules for poisons control. With the
development of the then European Economic Community later the European
Community and now the European Union (EU) with its twin aims of free
of goods between member states (MS) and consumer safety this situation
unacceptable. In 1976 the then MS agreed a Directive on Cosmetic
would be applicable to the Community as a whole. In the pursuit of
to technical progress this Directive has in the meantime been amended
than 24 times.
Other countries have developed
their own regulatory
styles but in the main these are based on those of one of the three
markets Japan USA or Europe.
In many areas of the world and
especially in the US the
cosmetic industry has embarked on voluntary programs aimed at improving
safety and effectiveness of cosmetics and at the same time at avoiding
intrusive government regulation. These activities have included codes
practice and self regulatory programs such as voluntary registration of
cosmetic manufacturing establishments cosmetic products and ingredients
voluntary reporting of adverse reaction experiences. In addition in the
industry has undertaken a program [the Cosmetic Ingredient Review
assess the safety of cosmetic ingredients through an independent panel
experts which meets deliberates and publishes its findings. CIR reports
specific cosmetic ingredients are used by industry and government to
the safety of these materials. In addition the perfumery industry set
international organizations IFRA (International Fragrance Research
and RIFM (The Research Institute for Fragrance Materials) to examine
perfumery materials and to control their use. The aerosol industry
code of practice for manufacture of aerosol products while the European
Chemical Industry set up ECETOC as a review body to control information
safety of chemical substances. COLIPA (Comite de Liaison des
Europeennes de1 Industrie
Perfumerie des Products Cosmetique et de toilette) the representative
trade associations within the FC published Advisory
Notes of Manufacturers together
with a number of other advisory
documents covering the safety of cosmetic and toiletry products. These
the Education and Training of Personnel
Product Safety Verification during Marketing and
Nitrosamine Formation in Cosmetic Products.
Although much of the voluntary
eventually led to legislation there still remains a wealth of voluntary
activity and the legislation imposed has been maintained at realistic
Industry continues to adjust its voluntary controls in the light of
environmental concerns and legislation in other areas that impinges on
products manufactured and sold as cosmetics and toiletries. Constant
and awareness of these issues is imperative for all scientists aspiring
create new approaches and new products in this area.
Regulation in the United States
Federal Regulation of Cosmetics
The Federal Food Drugs and
Cosmetic Act (FDC Act) is the primary food and drug law in the United
The FDC Act prohibits the distribution or importation of cosmetic
are adulterated or misbranded terms that have been interpreted by
Food and Drug Administration (FDA) and the courts to include certain
characteristics. However in general the term adulterated includes
are defective us safe filthy or produced under insanitary conditions. A
cosmetic may be adulterated if it or its container is composed of a
substance that may render it injurious to users under customary or
conditions. A cosmetic may also be adulterated if it contains any
or decomposed substance or if it has been produced packed or held in
conditions under which it may have become contaminated. Finally a
also be adulterated if it contains an unapproved color additive.
The term misbranded refers to
statements designs or pictures in cosmetic product labeling that are
misleading or which fail to provide required information and to the use
deceptive or improper containers. A cosmetic may be misbranded if it
bear all of the information required under both the FDC Act and the
of the Fair Packaging and Labeling Act (FPLA) which sets forth the
placement of information required on all consumer packages.
The FDC Act also requires
that companies maintain certain records and authorizes FDA to inspect
products and establishments including manufacturing and packaging
and other storage facilities vehicles used for transporting cosmetic
and containers of imported goods held at US ports of entry.
The Food and Drug Administration an
agency within the
Department of Health and Human Services administers and enforces both
Act and the FPLA. FDA conducts routine and regular inspections of
establishments in the United States to determine that products produced
and stored are neither adulterated nor misbranded. The FDA has not
manufacturing practice (GMP) regulations for cosmetics although
are also drugs are subject to the pharmaceutical GMPs. In practice the
inspection team generally conducts inspections at both over the counter
and cosmetic facilities. In addition to its routine inspection
will also investigate products and establishments on the basis of
complaints or because a company has filed a trade complaint concerning
possible violation of the law by one of its competitors.
Persons and firms responsible for
violations may be
subject to civil and criminal sanctions. Products found to be in
be seized and their further manufacture or distribution may be enjoined
orders obtained by FDA in the Federal court. If the offense is
or repeated FDA may bring a criminal suit against the company and its
responsible officials. Imported products that appear to be in violation
law may be detained at the port of entry by FDA inspectors and if found
in violation may be destroyed if they cannot be brought into compliance
not re exported.
Although FDA brings many
formal cases against violators and products each year it also works
domestic companies toward voluntary recall or correction of illegal
practices. This in part is due to the scarce resources of the FDA and
the FDA has the burden of proving that a product is either adulterated
misbranded. The first step in the FDA s enforcement procedures is
usually a warning letter to the responsible company or individual from
charging a violation of the Act and regulations and providing a limited
15 days for the company to correct the violation.
Despite the formidable enforcement
tools at the
disposal of the FDA cosmetics remain the most lightly regulated
the FDA s jurisdiction in large part because more stringent
not been needed. Cosmetic products may be placed on the US market
premarket clearance as long as the products do not contain any
unsafe ingredients (not adulterated) and are properly labeled and
misbranded). There exists no Federal requirement for cosmetic
registration or for listing cosmetic products or ingredients with the
regulations do include procedures for voluntary registration and
cosmetic establishments products ingredients and many industry members
participate in this voluntary program.
Safe ingredients Each cosmetic manufacturer is
responsible for using only safe and suitable ingredients in its
for substantiating the safety of the finished product. Products whose
has not been substantiated must bear a warning statement on the label.
to this author s knowledge no cosmetic product has ever been so labeled
event that a product is shown to be unsafe and is marketed without such
warning FDA could charge the responsible company with failure to warn
provision. This use of the misbranding provisions
of the statute together with the
adulteration prohibitions in the statute encourages voluntary testing
cosmetic products and ingredients prior to marketing.
The FDA has published a short
list of restricted or prohibited substances including items such as
mercury compounds for all but preservative use in eye area products
chloride halogenated salicylates zirconium in aerosols chloroform
chloride and chlorofluorocarbon propellants.
Color additives The FDA has also published
stipulating the color additives that may be used in cosmetic products
the product categories in which they may appear any restrictions in the
concentration level of the colors and any required label warning
The list of color additives is divided into those that must be
certified by the
FDA prior to their sale (all FD&C
and D&C colors) and so called natural colors
for which no certification is required.
In contrast to some other color
schemes most synthetic coal tar colors (the colors identified by FD&C and D
& C nomenclature
such as FD&C
Red 6) have not been authorized for use in products intended for the
The exceptions are FD&C yellow 5 FD&C Green 5
FD&C Blue 1 and
FD&C Red 40.
FDA s prohibition against the use of
poisonous or deterious substances in
cosmetic products does not apply to coal tar hair dyes as long as the
warning statement appears on the product containers. In addition coal
dye colors are not subject to the regulatory requirements for cosmetic
additives. The warning statement required by the FDC Act is as follows
Caution–This product contains
ingredients which may
cause skin irritation on certain individuals and a preliminary test
to accompanying directions should first be made. This product must not
for dyeing the eyelashes or eyebrows to do so may cause blindness.
The FDA has issued detailed rules
for the labeling of
cosmetic products. These rules are issued under both the FDC Act and
Because the FPLA applies only to the outermost containers of retail
packages some labeling requirements such as the ingredient declarations
identity statements and placement and type size of net content
apply to the outermost retail container. Cosmetics must be labeled with
information detailed in sections 1 to 6.
statement should appear
on the principal display panel (PDP) of the outer container in bold
type and in
lines parallel to the bottom of the package. The law does not require a
identity statement on the inner container of cosmetics that are
packaged in an
inner and outer container. However the inner containers of most
labeled with a product identity statement to avoid consumer confusion
potential misuse that could result in a product liability suit.
The name used may be the
common name of the cosmetic a descriptive name or of fanciful name (if
nature of the cosmetic is otherwise obvious) or the cosmetic may be
by an appropriate illustration of the cosmetic s intended use.
Products sold to beauty
salons for professional use by beauticians gifts of free samples
demonstrators and theatrical make up for professional use only are
product identity labeling requirements. However in practice these
generally are labeled with an identity statement of avoid user
potential misuse that could result in user injury.
Name and address of the
manufacturer packer or distributor The name and address of the
manufacturer packer or
distributor must appear on both the inner and outer containers. The
address may be deleted if the company appears in the local telephone or
directory. If the name that appears on the container is not the
must be prefaced by an explanatory phrase such as Distributed by Manufactured for Packaged by or a
similar description. The
name and address must be placed conspicuously on the product although
type size and placement are not required. Labeling the bottom panel is
generally considered to be conspicuous. The actual corporate name of a
corporation must be used. Partnerships individuals or associations may
identified by the name under which they do business.
The net content in American
(ounces/fluid ounces) and
metric measures this statement should appear in
American units within the lower 30% of
the PDP in lines parallel to the bottom of the package. If the PDP is
5 inch2 (32mm2) the declaration may appear
anywhere on the PDP. If there is more than
one PDP the declaration must appear on each. The required type size for
quantity of contents varies with the size of the PDP.
If a cosmetic is sold in an inner
and outer container
the inner container must also bear a net quantity of contents
However the type size and placement requirements for the net quantity
contents do not apply to the inner container as long as the statement
in a conspicuous location.
4. A statement of ingredients
in the product in descending order of predominance The ingredients are only
required on the outer container and generally are listed in order of
predominance in the product. The minimum required type size for product
ingredient statements is 1/16 inch (1.6 mm) except that 1/32 inch (0.8
be used if the total surface area available for labeling is less than
12 inch2. Placement must be on an
appropriate information panel (bottom panel
labeling is not generally considered appropriate).
Products sold to beauty
salons for professional use by beauticians gifts or free samples
demonstrators and theatrical make up for professional use are exempt
ingredient labeling requirements. Special ingredient labeling rules
certain cosmetic products such as lines of shaded products assortmemts
sold by mail order and products displayed in cases and display units.
Any warnings required by
regulation (such as the warnings required for aerosol products and bath
statements must be conspicuous and prominently displayed on both the
outer containers and in typesize no smaller than 1/16 inch (1.6 mm).
statements have been prescribed in the US for foaming bath products
hair dyes aerosol
products feminine deodorant sprays and for products without adequate
Country of origin if imported Us Customs Service
regulations require that cosmetic product containers be marked with the
of origin of their contents. Expiration dating and lot or batch codes
required by specific regulation. Most companies do include an
if the products are not likely to be sold and used within its period of
Lot and batch codes are commonly added to cosmetic product labeling to
facilitate recall and identification of products in the marketplace
for sensitivity to
cosmetics are divided into two general categories
establishment of the cuase of dermatitis produced by cosmetics in
Prophetic or predictive testing.
The ascertainment of the
irritant and sensitizing potential of new cosmetics before they are
to be used by the general public.
DIAGNOSTIC SENSITIVITY TESTING
establishment of the diagnosis of cosmetic dermatitis and the proof
cosmetic is producing a particular dermatitis is usually determined by
Technique of Diagnostic Patch Testing
be placed on grossly normal nonhairy skin. It is preferable to utilize
that are usually covered by clothing so that strongly positive patch
reactions which may persist for several days or even for a week or so
embarrass the tested patient. In rare instances hyperpigmentation
and even slight scarring may occur at the patch tests site.
covered patch tests a small amount of cosmetic is applied to 1 cm2 of
fabric gauze or Webril. This square may be backed with polyethylene to
occlusion and is held in place with a plastic adhesive tape such as
Dermicel is a nonrubber acrylate mass adhesive which is nonirritating
nonsensitizing. Blenderm is a similar acrylate mass adhesive.
investigators feel that the back is a reliable site for patch tests
pressure to which this area is subjected in sitting and laying enhances
of the upper inner aspect of the arm may also be employed for testing.
of this site enables the patient to readily remove any patch that
burns excessively. In general if it is suspected that a test substance
cause a severe reaction that substance should be tested at a site
the main body of the patch tests. This will enable the patient to
readily the reacting test patch without disturbing the other patches.
be given the following instructions after the test patches have been
any patch that causes
severe itching or burning but if possible do not disturb the other
Keep the patch test areas dry.
rubbing or scratching any
test site. Should you have to remove a patch the application of cold
compresses will help allay itching or burning and will not affect the
of the reaction provided that you keep the other patches dry. You may
aspirin or a sedative if necessary.
reaction depends on the sensitivity of the patient the concentration of
substance used for patch testing and the length of time that the
permitted to remain on the skin. Usually the patch test is kept in
place for 48
hr then removed and a reading made. When the patch is removed it is
mark the exact location of the test material on the skin with a skin
pencil or pen for future reference. This is especially true if the
the test are slight or doubtful and may have to be reread the next day
some later period. Readings should be made after an interval of 20 to
from the time of the removal of the patch. This time interval is
that the skin may recover from the effects of pressure of certain patch
substances which may produce a mild erythema or even dermographia which
usually transient. The true erythema of the specific reaction to the
persists for hours or days. The pressure of solid cosmetics may produce
temporary blanching that may stimulate a negative reaction and that may
positive only when the effect of the pressure wears off and allows
the eczematous response to come through the cutis into the epidermis.
The Interpretation of Patch Test Reactions
reactions to patch tests present changes in the skin characteristic of
As a rule the site of a positive patch test reaction itches. A
significant positive reaction consists of vesicles on an edematous red
When a single bulla occurs it is usually due to a primary irritant but
exceptions to this rule. When there is a questionable reaction such as
erythema it is wise to reexamine the patch test site the following day.
which persists or increases in intensity is probably significant for an
allergic reaction. Erythema at the test site which fades in 24 hr is
not associated with an allergic reaction of clinical significance.
test reaction with a cosmetic usually means that that particular
capable of producing allergic dermatitis provided the test has been
performed and interpreted. However it is possible on rare occasions for
cosmetic to give a negative patch test reaction when the test is
the usual sites such as the arm or back but give a positive reaction
applied closer to the site of the eruption particularly if the thin
skin of the
eyelids or neck is involved or if the cosmetic is a weak sensitizer.
sensitizers such as hair dyes or nail lacquer resins usually give a
reaction at the conventional sites of patch testing. However when a
cosmetic gives a negative patch test reaction the trial and error
method of re
application will usually establish its guilt or innocence.
a number of patches are
performed that cosmetic that is under strongest suspicion and may
reaction should be placed away from the other patches so that its early
if necessary will not disturb the remaining patches and so that a
positive reaction will not spread and produce false reactions at
versus Covered Patch Test
suspected of being photosensitizers should be tested both covered and
to sunlight or artificial light.
contain volatile chemicals may be primary irritants under a closed
include hair lacquers nail polish and some perfumes. Such cosmetics
allowed to remain uncovered on the skin at the site of the patch test
volatile substances have evaporated (usually for 10 to 15 min). After
period of time has elapsed the patch test site may be covered.
cosmetics which in actual use do not cause dermatitis may give false
positive patch test
reactions with the covered patch
test technique since they are primary irritants when occluded. The
should be tested uncovered depilatories permanent wave preparations
detergents hair tonics alkaline hair dye mixtures caustic agents
removers) oxidizing agents (certain freckle creams) mascaras containing
volatile elements shaving creams and tooth pastes that contain soapy
interpretation of covered patch test results with solutions of soaps
detergents is difficult. When these substances are suspected as the
allergic dermatitis testing should preferably be performed with such
ingredients as preservatives or antibacterial agents by both the
test method and open for photosensitization.
for testing cosmetics by the open method is to employ the use method in
the cosmetic simply is massaged gently into the forearm three times a
day for 3
days and the forearm is inspected for evidence of any reaction.
general primary irritants burn
rather than itch and produce reactions on the skin sooner than do
A primary irritant may cause a reaction in a few minutes to an hour or
a sensitizer usually requires 24 to 48 hrs to produce its effect. A
irritant reaction tends to remain confined to the site of the
the cosmetic and usually fades rather rapidly after the patch test site
been uncovered. Many allergic reactions tend to spread beyond the site
application of the cosmetic and to persist and even become more marked
several days after the patch is removed. It is however some times
very difficult to distinguish between a primary irritant effect and a
allergic eczematous reaction.
Features of Patch testing with Paraphenylenediamine
legislation requires that oxidation dyes such as paraphenylene diamine
bear a warning to the effect that a patch test should be performed
each and every application of the dye. In actual practice it is the
many beauty parlors to do a patch test prior to the initial hair dyeing
procedure but to omit the test on subsequent applications.
for allergic sensitivity to PPDA may be performed by either the
covered patch testing method.
Uncovered Patch Test Method for PPDA Sensitivity
is the routine technique for testing hair dye sensitivity. Instructions
such testing are included with every package of hair–dye preparation.
may be performed as follows five drops of the solution from the bottle
containing the dye should be mixed in a small glass with a similar
the bottle containing the oxidizing agent. The mixture is allowed to
5 min and is then painted on the skin at the bend of the elbow or
ear with a cotton tipped applicator. The application should cover an
less than the size of a 25 cent piece and should be allowed to dry and
on the skin uncovered for 24 hr. If at the end of this time there is no
or sign of irritation at the site of the application the dye can
safely used on the hair. If there is any sign of irritation at the site
application such as redness swelling papules or vesicles the dye should
should always be tested by the open method since the alkali and
oxidizer of the
mixture are primary irritants under occlusion.
Covered Patch Test Technique for PPDA Sensitivity
concentration of PPDA in petrolatum is standard for such testing. This
preparation darkens by slow oxidation and should be freshly prepared
months. Staining of the skin from a patch test with PPDA should not be
with an irritant or allergic reaction. Such staining is due to the
PPDA on the skin. PPDA for testing should be dispensed in a dark bottle
should be kept tightly closed at all times. Unoxidized PPDA and the
colored end product of the union with the hair probably are not
The intermediate partially oxidized quinone chemicals are said to be
Evaluation of Patch Test Reactions to PPDA
should that a 1 + to 2 + reaction to the PPDA hair dye mixture by the
method is of clinical significance and usually dermatitis will develop
hair dye mixture is used.
hand many individuals have been observed who show a similar mild
reaction to 2%
PPDA in petrolatum by the covered method and who continue to use PPDA
containing hair dyes without difficulty. However a stronger reaction (3
4+) by the covered patch test technique precludes the use of PPDA hair
Such strongly positive patch test reactions to PPDA are usually
allergic dermatitis if the dye is used.
cases the open patch test should be performed with the actual dye
was employed. If a positive patch test reaction is obtained the open
should be supplemented by testing with PPDA alone by the covered
positive patch test reaction by both methods proves that the PPDA was
of the dermatitis. Unless such a supplementary test with PPDA alone is
performed one cannot be certain of the actual cause of the dermatitis
patient has been exposed to several chemicals in the hair dyeing
with PPDA after 48 hr is rarely positive. After an interim of 3 to 5
reaction occurs. Such a delayed reaction may indicate that the test
itself has sensitized the individual. The application of the hair dye
in the interim
produces a dermatitis despite the original negative reaction.
an occurrence is extremely rare. At any rate performing a patch test
application of a PPDA hair dye is a legal mandatory requirement.
PPDA should be postponed until the dermatitis is under control. In the
phase of a dermatitis the skin may give a false positive reaction and a
strongly positive patch test reaction may cause a severe flare of the
with hair dye dermatitis
should also be tested with 2% para toluylene and 2% ortho nitro
paraphenylenediamine which may be present in certain oxidation type
of Patch Testing with Nail Polish
Patch tests with nail polish may be
performed by the
covered technique or by the open method. Where the closed patch test
used the lacquer is painted directly on to the skin which is not
about 15 min to allow evaporation of any volatile solvents that may be
The test site may then be covered. The sulfonamide formaldehyde resin
common cause of nail polish dermatitis is tested at a concentration of
In the rare instances where
photosensitivity to the
dye in the nail polish is suspected because of a history of flaring of
dermatitis following exposure to sunlight it is mandatory to perform an
patch test on an exposed portion of the skin or to perform photopatch
Testing with Lipstick
Lipstick should be tested by
both the open and the covered method. The open site is tested for
photosensitivity. Should the covered patch test be positive a
nonphotosensitizing azo dye the oils fats waxes perfumes flavors or
antioxidants (preservatives) used in the lipstick may be found to be
Upon request the
manufacturers of hypoallergenic cosmetics will send a raw material
containing individual lipstick bases and dyes for patch testing. To
results of the testing set these companies will also supply a clinical
set consisting of
sample lipsticks of
various colors for clinical trial and will prepare special lipsticks if
with Permanent Wave Solutions
Most modern permanent waving are
cold processes with
ammonium thioglycollate as the active agent. Added are perfumes gums
resin opacifiers lanolin and emulsifying agents.
Ammonium thioglycollate rarely
sensitizes. It may be
patch tested in a 10% aqueous solution. Permanent wave solutions should
diluted with five parts of water before being applied under a covered
nonspecific irritant erythema is often obtained by such testing
when the pH of the solution is high. Mild
erythematous patch test
reactions should not be considered allergic unless at least three
no reaction from the test.
Quality assurance serves the
purpose of making sure by means of planning direction and inspection
preparation meets the promises of the producer. Every effort must be
ensure that the consumer receives what he or she expects on the basis
advertising catalogue descriptions or directions for use. Consumer
must not be let down. Preparation quality must already be established
in the development
phase of a preparation. Legal guidelines regarding quality determine
development of a preparation. In order to ensure that a preparation
guidelines quality must be controlled. Quality control remains
under even the most modern technical conditions. Personnel and material
expenditures for quality control count as part of the normal conduct of
business . They usually account for about 5% corporate turnover.
Modern strategic planning
concepts is a company such as the just in time inventory can lead to
higher production costs. For example if a cosmetic ingredient or
component is as a result of this reduced inventory procedure no longer
purchased four times per year but rather six times per year and if
delivery is inspected as always the necessary control expenditures will
50%. This is of course not justifiable. Even quality assurance must
modern planning criteria.
The Analytical Laboratory Its
Significance for Raw Materials/Active Ingredients and the Finished Preparation.
raw materials and ingredients needed for cosmetic preparations are
usability in an analytical laboratory. The finished cosmetic
also tested here.
The prerequisites for optimal
chemical control (optimal is used here to signify the lowest
provides the highest degree of protection) are the most modern
technical aids such
as IR UV AAS spectrometers as well as gas chromatography and personal
computers. Qualified and experienced technical personnel are also
The Microbiological Laboratory
Assurance of Purity
and Hygiene. Without
technical aids molds or bacteria in cosmetic preparations are usually
recognized when it is too late. It is the task of a microbiological
to control their presence in cosmetic preparations. During production
cosmetic preparation it must already be known which microorganisms the
preparation is exposed to the germs discovered must be analyzed and
tested to ensure
that a precisely fixed germ count is not exceeded.
Sterile working conditions are not
cosmetic preparations but hygiene regulations must be observed during
production process. The GMP and GLP guidelines are generally regarded
applicable regulations. Cleaning and disinfecting are just as essential
provision of hygiene education to personnel. Only informed employees
that all regulations are adhered to. Disinfecting machines and machine
component are normally cost and time intensive. The clean in place
system is an
example of innovative attempts in this area which no business can
refers to washing cleaning and disinfecting machines by an installed
pipes without having to take apart machine components or pumps.
Raw Material Inspection
Specification is the
foundation for the inspection of cosmetic ingredients. It takes into
consideration the specific requirements of the company as well as legal
guidelines. Each detail of the specification must be coordinated with
producer of the raw materials. An inspection certificate which is given
user with each delivery makes it easier for laboratory administrators
which properties of the specification need to be subjected to chemical
analysis. It is not necessary to analyze every property of each
decision regarding how often to test is dependent upon the frequency of
delivery coordination of all specification properties between supplier
buyer the inspection certificate accompanying each delivery the history
raw material in question the degree of trust between buyer supplier and
complete documentation of all data. A sensory test of smell color
appearance together with an IR spectrum is often sufficient to identify
delivery accurately. The decision as to whether a full analysis of all
values needs to be carried out on every third fourth or fifth delivery
by the laboratory administration. It is also absolutely necessary to
analytical data in a personal computer. An evaluation of the raw
supplier can be made at any time with the help of this data.
of the Finished Product
instructions are essential for the production of the finished
Instructions regarding temperature mixing speed instruments or the
which ingredients are incorporated make it easier to keep to the
Here too an in process control which registers the actual values
speed etc.) in relation to the specified values should be adopted.
A particular risk can be
bound up with the weighing of the individual raw materials. However
inspection expenditures are (for example the additional presence of a
specialist from the analytical laboratory while weighing in active
mistakes by personnel cannot be excluded. For example too much of an
ingredient (such as a preservative) could cause fatal effects. For this
active ingredients are often inspected again by the analytical
laboratory as to
their proportion in the final preparation. This doubled or tripled
is cost intensive and hence not justifiable according to modern
quality. In the search for preventative test characteristics the use of
computerized weighing controls has therefore become prominent. A
manufactured under these conditions will generally meet the prescribed
of Containers and Packaging Materials
It would not be possible to
inspect each of 10 000 bottles delivered for packaging purposes. Yet it
guaranteed that they are all in flaw less condition. Breakage and
faults which would lead to leakage or glass splinters must be totally
It is impossible to compromise on this issue. The problem can be
the help of statistics. Probability statements regarding the specific
of a delivery can be made through the use of spot tests and fault
methods that practically eliminate error. The result of tests on a
representative sample of a total delivery is used to decide whether an
delivery of an item should be accepted or rejected. In terms of cost
analysis this is the only practicable system for inspecting large lot
quantities from the viewpoint of both buyers and manufacturers of
Modern business planning ideas such
as the previously
mentioned low level inventory method have had a decisive influence on
conceptions of quality for packaging materials. Statistics remains the
foundation of quality controls but checking systems have been developed
will be discussed here in some detail namely skip lot inspection source
inspection vendor certification and computer assisted delivery testing.
these inspection systems are related to the need to reduce control
without there by incurring greater risk.
Skip Lot Inspection. The cosmetics industry also
makes use of packaging materials which are relatively simple to
have therefore retained consistently good quality over the years but
delivery must nevertheless be thoroughly inspected. If the history of
packaging component has remained unchanged it is sufficient to inspect
third fourth or fifth delivery (hence the term skip lot). Precise
the packaging components and the supplier are however essential pre
for using this method of inspection. For deliveries which are not
identity check (appearance potential transport damage code number and
Source Inspection. Packaging materials that are
produced in large quantities and ordered in partial lots also do not
comprehensive inspection of each delivery. This is especially important
using the just in time inventory method where small quantities of the
are ordered with greater frequency. Source inspection requires that the
amount be statistically checked once by the producer. An identity check
sufficient for all deliveries of partial lots. In this case too
between supplier and buyer is necessary especially regarding the lot
order. A cost benefit analysis (expenditure on controls by the producer
transport costs versus savings) must be carried out to determine
whether to use
source inspection procedures.
Vendor Certifications. There are suppliers whose
preparations have proved themselves over the years to be of exceptional
quality. Packaging components supplied by them do not need to be
checked with every delivery since the risk remains small. A control can
via skip lot or source inspection methods at any time.
Computer Assisted Delivery Testing. An exact record and
evaluation of all available data is an essential prerequisite of the
mentioned tests employed in less frequent quality inspection methods. A
computerized system of measurement at the packaging delivery point
possible. Such a system is organized so that it contains all the basic
regarding a supplier and a component and the data from every further
procedure regardless of whether it is a skip lot or routine test method
into its memory. This happens automatically with every technical
because the measuring devices are linked to the computer. The results
attributive tests (of appearance color and so on) are entered manually.
analysis of a number of these tests shows immediately whether there is
tendency towards deviation from the norm or whether the values remain
within the specification. The computer is queried every time goods
provides the decision on whether to test that particular delivery. This
has proved its reliability in practice and can therefore be recommended
in every business.
Quality control that is
oriented towards testing after the fact does not meet the criteria of a
conception of quality. Prevention is the only possible means of
correcting errors and cutting costs. In process controls are
technical operational procedures which monitor the work process by
measurement devices integrated into that process. An example of this is
computerized weighing control of ingredients. In this system the
quantity of an
ingredient which is given in the formulation instructions is stored in
and automatically compared with the actual amount weighed. Each
communicated immediately by a signal or a printout. The sum of the
weight readings must correspond exactly to the quantity of the
Projections of the actual amount of a basic ingredient used in relation
target amount with reference to the amount in stock provides additional
Processes in the Manufacture of the Finished Product. Different companies offer
memory programmed management and inspection systems. Their purpose is
automate a mixing process with computer assistance according to
specifications. This optimizes effective time management of a facility
consistent reproducibility of the finished preparation as well as the
of formulation data. Control systems continually monitor temperature
speed and process duration.
These systems also help in
prevention or advance
inspection (in process control procedures). The check weigher belongs
group of systems for example this is a weighing system which is
the production line and automatically checks the weight of each
preparation. A computer evaluates the measurement results. In
facilities which cannot implement a check weigher weight inspection
during the production process by means of spot checks (computer
inspection of fill quantities). The evaluation and projection of
results at a central point provides certainty that the proper fill
are always contained. Torque measurement an ongoing check for container
and inspection of the finished product with automatic removal of faulty
those with missing labels or lot codes empty containers containers
or insufficiently filled containers are also possible in this way.
The systematic prevention of error
related to machines on the one hand and to human error on the other. In
production of the finished product this is especially important because
the last opportunity to spot and rectify errors before the product is
Specification features for the packaged preparation are prescribed by
Cosmetics Decree the finished Package Decree and the Guidelines for
well as by the internal company specifications. The manufacturer must
the extent of inspection activities in such a way that every
reaches the consumer fully meets all legal requirements.
A wide range of chemical and
natural materials is
used in the formulation of cosmetic and toiletry preparations. It is
the scope of this book to give a complete overview therefore only those
materials of primary importance will be stressed. This chapter deals
basic raw materials for the production of hair skin
and oral care products. It does not
include special additives such as herbal extracts nor raw materials
pigments for decorative cosmetics. An overview of herbal extracts is
The materials described are listed
rather than by chemical classification which is difficult to follow.
that some products are described twice for example the alkyl sulfates
surfactants and as oil in water emulsifiers but makes it easier to
overview of a specific field and allows the direct comparison of
ingredients. For each material the chemical pathway of production and
precautions regarding stability and compatibility with other
The purpose of a shampoo or shower
bath is to clean
the skin and hair. Customers also expect a dense and luxurious lather
this effect is not essential for the cleansing. To fulfill these
so called basic or primary surfactants which are the backbone of the
products are necessary.
Alkyl ether sulfates are the most
surfactants for cosmetics and toiletries due to their well balanced
The alkyl moiety usually consists
of a mixture of C12 C16 chins.
The degree of ethoxylation is between 1
and 4 (x=1 4). M is either sodium ammonium or magnesium.
In former times chlorosulfonic acid
was used in a
batch process. Today however the most common process for the production
alkyl ether sulfates is the continuous SO3 sulfonation
of ethoxylated fatty alcohols in a
thin film reactor followed by a neutralization step. The typical
lauryl ether sulfates or sodium laureth sulfate (CTFA Cosmetic Toiletry
Fragrance Association nomenclature) are based on alcohol mixtures. Well
accepted and approved for use in cosmetics and toiletries are the
based on natural alcohols derived from the
coconut palm (C12 approx.
70% C14 approx.
25% C16 approx.
5% ) the semi
from the Ziegler process (C12/C14 approx. 50/50%) and the
partly branched SHOP alcohols (C12 C13 C14 C15 approx.
20 30 30 20)
The properties of alkyl ether
sulfates are largely
determined by the number of ethylene glycol units in the starting
alcohols. Figure 1 shows the influence of the degree of ethoxylation on
compatibility as measured by the Zein number (an in vitro measurement
irritancy of surfactants). The presence of 2 to 3 ethylene glycol units
to ideal behavior regarding foam and detergency. Such alkyl ether
easily thickened with salts and show good water solubility even at low
temperatures. The skin and eye compatibility is acceptable for most
applications but is usually improved by combination with mild secondary
surfactants. Higher degrees of ethoxylation up to 8 or 12 can
reduce irritation. Combinations of these highly ethoxylated ether
the magnesium form with normal ether sulfates are recommended for baby
Alkyl ether sulfates have
been found to be a source of relative high levels of 1 4 dioxane. Up to
of this impurity has been found in shampoos. The impurity at this level
presents little or no health risk but improvements in the sulfonation
have resulted in lowering of the dioxane level below 20 ppm (calculated
active matter). This level of dioxane is now standard for ether
Water based and salt free
alkyl ether sulfates are commercially available in two forms (i) low
(27 30% active matter) a low viscosity clear solution and (ii) high
(70% active matter) a translucent paste with pseudoplastic flowing
low concentrations the ether sulfates form spherical micelles which are
transformed into rod like micelles when the concentration increases. At
50% active matter these rods are tightly packed and form a hexagonal
stiff gel. At 70% active matter a sandwich like structure the liquid
crystalline lamellar phase appears. The layers can glide on each other
product is easily pumpable. Advantages of the 70% form are (i) reduced
transport costs (ii) increased storage capacity and (iii)
safety without the need for preserving agents. The concentrate must be
above 20°C and needs special equipment for dilution because the gel
between 30 and 65% must be passed through. Technology is available for
batch and continuous dilution. The principle is always the same to
speed of dilution a large surface has to be formed using colloid mills
Alkyl sulfates were the first
synthetic surfactant to
be used in large quantities in cosmetics and toiletries and in some
including the USA they are still the most popular. The alkyl sulfates
cleansing products are usually lauryl derivatives (alkyl=C12 to
C16). As in the case of the ether
sulfate the starting alcohols are seldom
pure. Sodium ammonium mono and triethanolamine magnesium and other salt
are present in concentrations of 30 40% active product diluted in water.
Alkyl sulfates are excellent
foamers producing a rich and creamy foam but are unstable in hard
is not a problem for shampoo or shower applications but means that they
be used as the main component in foam baths. Instead they must be
surfactants such as olefin sulfonates or sulfosuccinates which are
hard water. The sodium forms of fatty alcohol sulfates are not very
low temperatures and formulations with high amounts of sodium lauryl
often cloud up at temperatures below 5°C. Triethanolamine (TEA) salts
better cold temperature stability but relatively higher amounts must be
since TEA represents nearly one third of the molecular weight and does
contribute greatly to foaming and cleansing properties of the
TEA is a type of solvent. With respect to solubility the ammonium form
somewhat better than the sodium form but the formulation must have a pH
of 5 6.
5 since at alkaline pH ammonia will be liberated.
A negative point of the alkyl
sulfates is their high
irritation value although an exception is magnesium lauryl sulfate
combines the mildness of a secondary surfactant with the good cleansing
foaming properties of the primary surfactants. Figure 3 gives an
the irritation index of several surfactants as determined by the Zein
This laboratory test correlates well with in vivo
test results. The high
irritancy of the sodium alkyl sulfates is one reason why alkyl ether
are often preferred in liquid formulations while sodium cocoyl
preferred in the field of syndet (synthetic
A very important application of
alkyl sulfates is
their use in toothpastes. Sodium lauryl sulfate is available in very
with low amounts of unsulfated matter. This results in a very neutral
compared to the bitter taste of other surfactants.
Chemically both alkyl sulfates and
sulfates are esters of sulfuric acid and are therefore unstable at
values. In this case the hydrolysis is an autocatalytic process where
velocity of hydrolysis increases with decreasing pH. This is mainly a
regarding storage at elevated temperatures but should also be taken
account during the development of formulations with low pH values.
Olefin sulfonates are a mixture of
and hydroxy alkane sulfonates prepared by sulfonation of a olefins
alkaline hydrolysis. Contrary to most other surfactants where the C12 alkyl
chins show the highest
surface activity olefin sulfonates show maximum activity when C14 and C16 olefins
are used. In the first step of
production which is the sulfonation in a thin film reactor alkene
and sultones are formed. These sultones are then hydrolysed into alkene
sulfonates and hydroxy alkane sulfonates. The mixture usually contains
60 65% of alkene sulfonates 35 40% of hydroxy alkane sulfonates and up
of disulfonates. The olefin sulfonates are commercially available as
with approx. 40% active matter.
From Figure 3 it can be seen
that olefin sulfonates are milder than alkyl sulfates and of similar
to the alkyl ether sulfates. An in vivo test did
between olefin sulfonates and ether sulfates.
Olefin sulfonates also
produce an excellent flash foam when used in cold water and are
particularly recommended for liquid hand soaps. They are stable in hard
and show hydrotropic properties. This results in low cloud points on
high solubilizing power for superfatting agents. The difficulty of
can be overcome by combination with other surfactants. For example a
60% olefin sulfonate and 40% sulfosuccinate which are individually very
difficult to thicken shows a thickening behavior comparable to alkyl
sulfates. Contrary to the alkyl sulfates and the alkyl ether sulfates
sulfonates are stable at both acidic and alkaline pH values.
Olefin sulfonate is a well
established basic surfactant particularly in the US and Japan.
toxicology it is one of the best known anionic surfactants besides
sulfate. Today s technology allows the production of light colored
Linear alkyl benzene sulfonate and
are very powerful surfactants with good detergency and foaming
However due to their strong defatting action they leave a harsh and dry
skin and hair. For very cheap formulations small amounts can be used to
the costs of raw materials. Their main use is in dish washing liquids
Mild anionic surfactants
Compared to the basic surfactants a
much wider group
of mild anionic surfactants is used in cosmetics and toiletries. The
mild or secondary surfactants is to improve skin and eye compatibility
formulation. On the other hand mild surfactants usually show reduced
and cleansing compared with basic surfactants. Fortunately there are
synergisms for combinations of surfactants which are known to
partially compensate for this behavior.
Sulfosuccinates represent a
diverse group of derivatives of sulfosuccinic acid. Both mono and
known. The diesters particularly the sodium diethylhexyl sulfosuccinate
very effective wetting agents for industrial use while the monoesters
surfactants with good foaming properties and are widely used in
toiletries. Sulfosuccinates are prepared in a two step process. The
is the esterification of maleic anhydride with an alcohol. This can be
example a fatty alcohol an ethoxylated fatty alcolol a fatty acid
monoethanolamide or an ethoxylated monoethanolamide. The second step is
sulfonation of the resulting half ester with sodium sulfite.
The most popular derivative
used in Europe is disodium laureth sulfosuccinate where laureth refers
ethoxylated lauryl/myristyl alcohol with approx 2 3 moles ethylene
the USA sulfosuccinates based on amides particularly the disodium
sulfosuccinate are more important.
The sulfosuccinates have good
skin compatibilities compared with the basic surfactants. In general
based sulfosuccinates are better than the alcohol based types.
are good formers and are relatively cheap. A disadvantage is their
at both low and high pH values. The highest stability is obtained at pH
between 6 and 6.5. The ethoxylated forms are stable in hard water and
useful lime soap dispersants. They are mainly used in liquid
non ethoxylated forms are good co surfactants for syndet bars.
are relatively poor solubilizers for perfumes.
The cocoyl isethionates can be
prepared in two ways (i)
by the direct esterification of sodium 2 hydroxyethansulfonate with
fatty acid and (ii) by condensation with fatty acid chloride which
amounts of sodium chloride in the product.
Cocoyl isethoinate is mainly used
as a surfactant in
syndet bars. In normal soaps it improves skin compatibility and acts as
soap dispersant. The extraordinary mildness of this surfactant has been
by more than 30 years experience. For syndet bar production
as stearic acids fatty alcohols or waxes are used. Cocoyl isethionate
relatively insoluble in these plasticizers but has to be dispersed.
Consequently cocoyl isethionates are usually offered as extremely fine
with a particle size below 40 m . Ready made premixes in noodle form
combinations or platicizers with cocoyl isethionate and other
also available to the cosmetic formulator.
At room temperature cocoyl
isethionate shows only
limited solubility in water. This permits its use in syndet bars but
to crystallization in liquid preparations that are not properly
to its excellent skin compatibility and emolliency properties the use
cocoyl isethionate in baby products and in facial wash formulations has
reported. Since it is an ester cocoyl isethionate shows maximum
the pH range 5 7.
preservation of cosmetics
preservation of a
cosmetic product is a very difficult and complex task. Preservation is
retarding or prevention of deterioration of the product from the time
manufacture until the time that the consumer completely uses up all of
product in the container. The cosmetic manufacturer would of course
like to see
all products manufactured sold to the consumer and used up in the
possible time. However he cannot assume that this will be the case.
this he must try to stabilize products and prevent them from changing
periods of storage and under exposure to many varying conditions of
In any product
there are many
changes that may occur. Emulsion products may change viscosity cream or
completely break down. Clear products may become cloudy. The package
with the product or conversely the product may react with the package.
color of the product may change with time temperature or light
actives in the formulation may break down and the perfume or dye system
deteriorate. The oils in the product may become rancid. Microorganisms
suddenly overrun the product. Many types of reactions and interactions
occur at the same time. The cosmetic chemist must anticipate as many of
problems as possible and try to eliminate them by good formulating
and packaging techniques.
are really one and the same. The term preservation as can be seen from
above means more than just stabilizing the product against attack by
always been some
tendency to confuse the terms preservative antiseptic disinfectant and
germicide when referring to antimicrobial properties. Preservative in
sense means any material that would react with prevent the growth of or
microorganisms that might harm products or grow in products. Antiseptic
to substances that prevent the growth of or destroy microorganisms when
substances are applied to living tissue. Disinfectants destroy disease
producing microorganisms on inanimate objects. Germicide is a more
meaning any substance that kills microorganisms. It must be remembered
none of these terms refer to compounds that have the ability to
completely. The reason is that none of the compounds in any of these
can destroy all spores. Preservatives generally do not make good
disinfectants but the reverse is not necessarily true.
that occur in
products are due to physical chemical microbial or enzymatic reactions.
accelerated and normal stability testing studies a continual watch must
for any change that might occur. Physical changes such as increasing or
viscosity changes in surface tension changes in the feel of the product
in color changes in odor package distortion corrosion or permeation of
container must be noted investigated and prevented. Chemical changes
degradation of active ingredients interactions of ingredients and
ingredients with packaging materials or with manufacturing equipment
of construction) must be prevented. Microorganisms may grow in the
add color or their enzyme systems may break down emulsifier systems
active ingredients use up all of the antimicrobial preservative and as
destroy the product.
microorganisms need water
present to grow. There are however a number of organisms that will
completely anhydrous systems. Because of this every cosmetic
have a preservative in it. If the product contains vitamins hormones
acids lipids or albumins it will be particularly sensitive to
many of them will break down these compounds. If oils or fats are
the product the problem of stability is increased even more because
materials can be oxidized. Emulsions having oil as the continuous phase
much less subject to microbial attack but can still suffer from
by oxidation of the oil.
formaldehyde alcohol boric acid salicylic acid and its derivatives and
acid and its derivatives all have drawbacks to their use. To be
acids and their derivatives can only be used in a limited pH range.
cannot be used in the presence of proteins and many other substances
formaldehyde is odoriferous and can easily react with many dye and
systems. Numerous investigators shared the opinion that of the
general use the esters of p hydroxybenzoic acid are the preservatives
since they approach the requirements of the ideal preservative most
course these investigators had no way of knowing that many years after
made this statement these same esters would react with a new class of
emulsifying agents the nonionics which would then decrease their
Also these investigators could not possibly have known that at an even
time people would prove sensitive to these same compounds.
There is no
right preservative or
wrong preservative for every situation as there is no right or wrong
for every formula. The choice of ingredient that is used is even today
empirical. Because when preservation is mentioned microorganisms come
to mind those
that are found in cosmetics as contaminants are gone over in detail.
ORGANISMS FOUND IN COSMETICS
filamentous fungi and
are widely distributed throughout the world in soil and water and as
in plants and animals. They are unicellular or multicellular fungi.
average size is about 30 in diameter. They may be black brown green
white. Molds can have thread like long filaments called hyphae. These
may be branched or unbranched or may be divided into cells (then called
septate). These cells in the hyphae have one nucleus in each cell or if
have a nonseptate hypha you can have more than one nucleus.
The molds due
to the appearance
of their matted hyphae (called mycelia) are usually velvety in
perhaps cottony. Their hyphae burrow into the substrate and large
heads that are usually pigmented are grown. These spore heads
the spores or open (in the case of sporangia) the spores fall and if
a moist surface they begin to germinate. Molds may reproduce by budding
sexual means (zygospore formation) as well as by spore formation.
best at room
temperature. They require moisture and darkness to grow. The pH must be
2 and 5.5 but the best pH for them is 4.5 to 5.5. They will not grow in
alkaline or neutral environment. Molds like a media with high osmotic
such as liquids with high concentrations of salts or sugars. The molds
contaminate cosmetic products are mainly saprophytic. They grow best on
down decaying organic matter.
It is only
within the past 10 to
15 years that we have started to get more extensive information in the
literature regarding the identification of organisms found in spoiled
and drug products. In 1954 de Navarre pointed out the need for more
done in this area and in 1957 he published a report on the isolation
identification of a mold Paecilomyces varioti that was found growing in
emulsion system. Paecilomyces varioti is a mold that is very similar in
appearance to Penicillium and Aspergillus. Its sterigmata are short and
tapering into long conidium bearing tubes mostly curved or bent
from the axes of the main sterigmatic cells. This mold was found
a cap liner and contaminated the product while it was in use. The
this organisms are fairly resistant which may account for their
presence in the
closure liners the material of which is subjected to heat and chlorine
treatment. This mold grew well on the emulsion and was a brown gray
1952 described the
contamination of cosmetic products by molds. The following are probably
most frequent molds found in cosmetics.
widespread genus of fungi most often seen as a green velvety growth.
mycelia are a network of fine branching tubular threads with cross
marking off cell limits. Some of the branches are characterized by a
fingerlike branches at the tip at the end of which long chains of
single celled spores occur. It appears colored green blue green or
will grow on almost anything with an acid pH. This fungus is able to
proteins fats and carbohydrates.
can be green yellow brown
or black. The spores are borne in chains as with the Penicillium but in
case the tip of the mycelial branch bearing them is club shaped.
also needs slightly warmer growing conditions and more nutrients than
Pencillium. It will grow on many crude drugs such as rhuburb because of
presence of acids and anthraquinones.
Mucor have mycelia
that show no cross walls and their spores are produced inside a globe
sporangium. These fungi also produce thick walled resting cells
a rudimentary sexual process.
commonly as the black bread mold. Its large black sporangia can be
distinguished with the naked eye on the surface of a fluffy white
mycelia. This mold requires more moisture to grow than either
grows as a silvery
gray turf of mycelia. Its sporangia are grayish and are borne on single
threads branching off the main mycelia. It too is widespread and may be
on a great variety of decaying organic matter. Its moisture
the same as those of Rhizopus nigricans.
cinerea is commonly
found on decaying organic material and is commonly associated with
disease. Vegetative growth is fluffy gray white to dark with small
celled spores borne on crowded fine warty swellings along the rounded
upright branches somewhat in the manner of bunches of grapes. It is
found in cosmetics but Nowak has reported finding it in creams where it
subsists on the fatty acid residues of soap substances.
usually dark in
color greenish black with creeping vegetative mycelia which send up
unbranched threads at the ends of which chains of large many celled
are formed. These spores are usually pear shaped and have numerous
cross walls with
the cells arranged like irregular bricks in a wall. In 1946 Holt and
found this mold contaminating creams and lotions. This mold was found
in the sealer of the caps that were used on the product.
in occurring as dark spreading mycelia with club shaped muriform
However these spores are borne singly at the tips of short upright
rather than in chains. The fungus is found as a saprophyte on decaying
matter or as a very mild secondary parasite on plant lesions caused by
is a soil fungus
with dark greenish black mycelia. Its spores are usually olive green
appear in chains which branch in a tree like fashion on upright
threads. They are small oval bodies at first one celled but often
cross wall as they mature.
herbarum has been
isolated by Cox and Sewell from a hydrocortisone cream where it was
found to be
metabolizing the steroid.
containing no chlorophyll but they may contain pigments (yellow pink
red green or
black). They do not form hyphae are ovoid or spherical in shape and
about 5 m in diameter but they can be anywhere from 5 to 30 m in
have a nucleus and they reproduce by budding fission or ascospore
is believed that yeasts are degenerate forms of fungi that have lost
ability to produce hyphae. They are nonmotile have a thick cell wall
cytoplasm may contain granules of glycogen and volutin as well as small
vacuoles of fat. Yeasts cannot manufacture their own food and therefore
depend on higher plants and animals for their energy. They obtain
aerobic oxidative dissimilation or by anaerobic fermentation. Most
grow best on any medium containing fermentable sugar will grow over a
of 2.2 to 8 (although most yeasts prefer acid conditions) and usually
at room temperature. They usually require an abundant amount of oxygen
are usually small
celled yeasts. They reproduce by budding and they can easily ferment
solutions as long as the minerals that they require for growth are
Saccharomyces ellipsoideus contains some strains of yeast that will not
contaminate by fermentation but will in the process cause the
aldehydes and ketones that will completely destroy the flavour of the
(formerly known as
Torula) reproduces by budding forms little or no hyphae (when hyphae
are very short) are never dark or brown but can in some cases form
pigments. These organisms are important because one species will
lactose and another Cryptococcus neoformans (formerly known as Torula
histolytica) is pathogenic to man. Yeasts of this genera have been
the literature as being found in cosmetics or in the plant where
pharmaceuticals were being manufactured.
(formerly known as
Monilia) is also a yeast that reproduces by budding. At times it may
short hyphae. Members of this genera have been reported found in
This is very important because these organisms can be pathogenic to
Candida albicans is the usual culprit and can infect the skin nails
membranes of the oral and vaginal cavities and can occasionally be
found as a
secondary invader in lung abscesses and other chronic pulmonary
contaminator of rouge and paste dentifrice and Saccharomyces apiculatus
contaminator of cosmetic packing cartons has been found by Babicka and
to by de Navarre.
are much more
difficult to generalize about than are either the molds or the yeasts.
reason is that there are so many different known species (more than
of which thrive under very unusual conditions. Most bacteria are quite
0.5 to 3 but there are species that are as large as 100. Bacteria are
celled organisms that reproduce by binary fission are affected by
pressure and surface tension and are usually killed by high temperature
(although some spores can survive in boiling water for as long as
hours). The optimum temperature for the growth of most but not all
37°C. Bacteria do best on a media that is slightly alkaline pH 7.2 to
7.6. At a
pH of 6.5 most yeasts and molds will thrive but many types of bacteria
killed. Bacteria need moisture to grow although spores will resist the
moisture. Many bacteria are killed by exposure to ultraviolet light or
bacteria have been
reported at one time or another as contaminating cosmetic products.
reported finding Aerobacter aerogenes Pseudomonas aeruginosa Bacillus
pyocyaneus Alcaligenes viscosus and Pseudomonas fluorescens. Also
Babicka and referred to by de Navarre were Bacillus subtilis
albus Bacillus mesentericus Achromobacter lipolyticum Bacillus mycoides
roseus Escherichia coli Sarcina lutea Serratia marcescens Bacillus
Staphylococcus citreus Escherichia paracoli and Bacillus astrosporus.
This by no
means was to be
considered an attempt to find every report of every case of microbial
contamination in a cosmetic product. Many other cases of contamination
listed and discussed in other sections. It is important that the reader
some idea as to the number and variety of microorganisms that can grow
cosmetic products if extreme care is not taken during formulation
packaging of the product.
antiperspirants and DEODORANTS
on a historical perspective
antiperspirants and deodorants are relatively new personal care
a 100 year span of development and use. One can appreciate the
advancements of these compositions considering that over 300
passed during which some kind of cosmetology was crudely practiced.
extracted oils fragrances and metallic based ointments were extensively
for skin care eye and facial décor.
20th century the antiperspirant active choices available to consumers
This undeveloped cosmetic science together with poor product delivery
applied to the axillary body region was considered nothing less than
known marketed deodorant product was a zinc oxide based cream
introduced within the United States in 1888. Through the years zinc in
salt forms has been evaluated for its antiperspirant and deodorant
The incorporation of zinc halides into basic aluminum and zirconium
complexes has resulted in salt complexes described as useful
possessing good alcohol solubility. Zinc metal complexes however were
adopted into the Category I antiperspirant active listing. Other zinc
compounds known to have deodorant potential were zinc peroxide zinc
zinc sulfocarboxylate and zinc sulfide.
1960 s zinc phenolsulfonate was introduced in aerosol form and was
hexachlorophene. The effective antimicrobial action of the two
quickly led to high consumer acceptance and some cannibalization of the
old roll on antiperspirants. Today zinc phenolsulfonate is one of the
clinically accepted zinc salts that can be found in deodorant
Hexachlorophene however has banned in the mid 1970s due to potential
penetration and neurotoxicity.
antiperspirant was a non formulated product consisting of a dilute
solution of aluminum chloride. The application was simply one of cotton
swabbing the axillary area and waiting for the sting and water to
that order. Aluminum chloride despite its strong acidity is perhaps the
effective active to this day. It can be found in pharmacies in a
dosage of not greater than 15% on a hydrated basis in non aerosol form.
1900s aluminum salts were primarily the only active ingredients
effective in reducing sweat and controlling odor. Efficacy was not
until 1916 the first published report appearing in the journal of the
Medical Association. At the same time promotional campaigns were under
leading to national popularity from aluminum chloride solutions.
clearly lacking from the simple solution forms of anti perspirant but
by 1930 cream
compositions were introduced containing aluminum sulfate in wax bases.
with current standards the esthetics may appear to have been derived
cosmetic science but were in fact elegant to the consumer of that era.
88% of the US antiperspirant market was in the form of creams the
share of an antiperspirant from ever to exist.
hand squeezed aerosol and roll on antiperspirants made their way onto
market representing unique delivery forms. The package technology was
perfected however leaving the consumer with convenient but often faulty
delivery systems. The attractive features were the fact that the
could now be applied without the use of fingers. Popularity grew slowly
early as the next decade or roll ons dominated the market over creams
short period of time.
era phenomenal changes occurred in the way aerosols were designed.
and antiperspirants were incorporated into pressurized propellant
metal containers leading once again to high consumer acceptance. Valve
perfection coupled with anhydrous suspension compositions dramatically
rate of clogging. By 1973 aerosol forms achieved greater than 80%
The huge success of aerosols sparked interest in many countries.
two thirds of the UK antiperspirant and deodorant market is in the form
the United States can be remembered as an era of growing environmental
awareness which hit hard on aerosol compositions. Both fully
chloroflurocarbon propellants and aluminum zirconium complexes were
from use in aerosols and sprays leading to the fastest market decline
antiperspirant/deodorant category ever witnessed.
formulary ingredient ever recognized for esthetic improvements came
the same time that aerosols were under fire. The generic name for this
additive was cyclomethicone. It possessed high esthetic and lubricative
properties which led to rapid technological advancements in suspension
and sticks. These anhydrous suspension systems have become consumer
and today more than 80% of all antiperspirant formulations contain
cylomethicone. In Europe and other parts of the world aqueous based
and sprays dominate suspensoid stick compositions. The existing
antiperspirant/deodorant market comprises roll ons sticks aerosols gels
creams. Since 1985 consumers have had the choice of conventional and
performance types. The US market history of antiperspirant and
graphically illustrated in Figure.
products antiperspirants have been regulated more stringently by the US
and Drug Administration both with respect to the active raw materials
finished product compositions. Up until 1938 there were no regulations
to cosmetic materials. The Food Drug and cosmetic Act which was enacted
by the federal government clearly stipulated that deodorants which did
alter a bodily function were viewed as cosmetics but antiperspirants
affected the operation of the sweat glands were considered drugs. This
physiological concept is interpreted in basically the same way today
out the world however labeling and testing requirements for cosmetic
vary from country to country. The United States has initiated the most
labeling requirements and Canada probably leads in the most
as classified as over the counter (OTC) drugs and deodorants are
cosmetic products. The regulatory control tightens specifically when
made by the manufacturers of such products.
rules for classifying OTC drugs were drawn up in the Federal Register
by the FDA. The last final tentative drug monograph CFR 21 part 350 was
published in 1982 and since then it has been regarded as the only
spell out rules regarding safety clinical testing and active
Labeling of OTC drugs is discussed in CFR 21 part 201.
the tentative final document Category I antiperspirant actives which
effective in January 1995 were adopted by United States Pharmacopoeia
drug compounds assuming identity standards and test methods consistent
requirements Currently additions and modifications are underway to
coverage of Category I actives. The specifications will include the
of elemental atomic ratios solvents and concentrations. The changes are
consistent with the industries use or intended use with in the
already permitted in CFR 21 part 350. For commercial considerations
actives listed in Category I should be of interest to the formulator as
in the Table 1.
Mechanism of sweating
Antiperspirants are intended for
use in the axilla
region of the human anatomy. This area contains aprocrine eccrine and
glands. These glands generate fluids and chemical substances which
leads to the
development of body odor. The eccrine glands average about 200 per
and produce the majority of sweat. The eccrine secreted fluid is
composed of a
hypotonic solution of sodium chloride urea lactates and other metabolic
The sebaceous gland is a sub surface gland evidenced by a hair
excretes lipids and fatty acid substances which are responsible for the
generation of coryneform bacteria. The apocrine gland also a sub
with a protruding hair follicle secretes lipids cholesterol and
biological degradation of certain steroids by coryneform bacteria is
responsible for the development of odiferous compounds. The total
still not fully understood.
production of sweat by the eccrine glands
is initiated by both emotional thermal and sensory stimuli. The actual
mechanism is some what complicated in the sense that water is not just
through the sweat duct to the surface. The transfer of sweat fluid
the enzymatic degradation of Na+/K+ ATPase within the basal membrane.
movement of Na+ ions across the luminal membrane in the secretory coil
an osmotic pressure gradient. The relief of this gradient condition is
accomplished by the movement of water across the cells of the sweat
secretory coil into the lumen. This movement of water continues under
stimuli increasing luminal hydrostatic pressure. The excess fluid
to the absorptive duct in the secondary coil and proceeds to the pore
on the skin.
There are a number of teories about
antiperspirants affect the sweat gland to diminish the flow of fluid.
the earliest investigations by Shelly and Horvath suggested that
were created when aluminum chloride was used to treat the axilla. This
challenged as being more of an injurious effect causing a cell
to restrict flow. Papa and Kligman theorized that aluminum chloride
sweat duct causing cell erosion thus allowing for sweat to leak from
duct into interstitial spaces rather than flow to the skin surface.
postulated that the pores swell shut when contacted by antiperspirant
The most respected theory which has
substantiated by many scientific evidences is the hydroxide plug
aluminum and other metallic salts. This theory best coincides with the
hydrolysis chemistry of aluminum chloride and its basic salt complexes.
complexes are polymeric in nature and possess a high degree of cationic
relative to the average molecular weight of the polymer distribution.
chloride has the highest charge and lowest molecular weight compared to
lower charges of higher molecular weight basic aluminum halides. Table
illustrates the charge to weight relationship in polymer development.
should conclude that the smallest polymer size spices with high charge
enter the sweat duct by some migratory movement perhaps assisted by
attraction. During this journey in a very diluted state neutralization
by hydrolysis occurs causing the hydroxide plug to form in the
intraepidermal ducts there by restricting flow. These plugs in fact
confirmed using electron microscopy and aluminum fluorescence
detect the presence of the gel.
Studies by Quatrale have been
conducted on the antiperspirant action of aluminum chloride aluminum
chlorohydrate (ACH) and aluminum zirconium glycinate (AZG) during
By performing cellophane stripping of the applied axilla region it was
demonstrated that hydroxide plugs from aluminum chloride were found to
deepest and most difficult to remove. The restoration of the affected
glands back to normalcy was slow. ACH hydroxide plugs were next easiest
restore followed by AZG. One would have expected AZG hydroxide plugged
to be deeper and restore slower than ACH because AZG typically
% relative higher sweat reduction than ACH. It should also be
that under dilute conditions as would be the case in underarm
growth for most AZG compounds exceeds that for ACH. This faster more
superficial hydrolysis at an earlier stage of migration into the duct
AZG an effective antiperspirant.
Currently there are numerous
polymeric versions of ACH and AZG with enhanced or activated
types of the enhanced salts are offered in dry powder form but there
aqueous and propylene glycol complexes that are stable as well.
It is advisable for the
formulator to have a polymer finger printer for each particular batch
active to ensure that the physical properties are consistent with those
during the developmental stages of formulation. A chromatographic
an enhanced active is the only means of verifying potential
2(a) (f) illustrates various polymer distributions of the aluminum
The formulator should also be familiar with other physical properties
active found during the research and development stage so that scale up
better understood. Process variables can impart changes to the active
The hydrolysis of trivalent
aluminum is extremely complicated. The formulator who incorporates
polymer blends should be aware that solvated forms of BAC will in fact
different polymeric equilibrium under certain conditions of use. Such
conditions would include the dilution of active with polar solvents
temperature time and the use of pH altering additives. Most marketed
concentrated basic aluminum chlorides will show a shift both in the
size distribution and structural coordinates during the formulation
This can be lead to reduced efficacy.
Conventional aqueous ACH is the
most popular form of
BAC which is normally supplied as a 50% hydrated salt solution. It is
miscible with anhydrous ethanol propylene glycol glycerine and most low
molecular weight polyols. The typical polymeric distribution for ACH
aqueous solution shows 35% peak 2 polycations of about 8000 gm 1 60%
peak 3 intermediate
polycations of about 5000gm 1. 3% peak 4 Al13 polymers
of about 3000 gm 1 and
2% peak 5 oligomers and
monomers of less than 2000 gm 1.
The nominal empirical formula
for ACH is Al2(OH)5Cl22¼H2O and and the anhydrous active
content of a 50% solution is 40.5%. BACs
are permitted in all types of formulations not to exceed a maximum
dosage of 25%. A formula containing ACH 50% solution should not
greater than 61.6% of the total composition. Aqueous ACH is primarily
roll on emulsions pumps creams and gels.
ACH is also marketed as a dry
powder that is available in various particle size distributions. ACH
corresponds to the same nominal empirical formula as the aqueous
except that the anhydrous active content is 81%. The balance is both
Variation in particle properties
can impart different
characteristics to a formula. Discretion is often necessary to match
powder form with the application.
In an unmicronized state ACH is
in nature. This form is sometimes referred to as crystal powder or
can be used in this form with some economic advantage because the
process stage is not exercised. The formulator should make certain that
random distribution is 100% less than 100m since
this is the critical
size at which the consumer can begin to detect grittiness during
and use. One advantage of using unmicronized powder is that the
density can be readily controlled during manufacturing. This affords
formulator better control of the suspension characteristics in lower
systems. Apparent bulk densities can vary between 0.2 –0.9 gcm 3
values of about 0.5 g cm. The critical particle density in
cyclomethicone is about 0.24 g cm .Unmicronized ACH with higher density
narrower distribution has some utility in aerosol sprays because it
deliver a better controlled spray pattern. Such distributions contain a
fraction of particles below 10µm.
Micronized ACH is available
in various particle size distributions depending on the application.
industry standard grade more often than not will be found suitable for
most suspension systems. The standard particle size specification for
controlling distribution is 97% minimum less than 325 mesh. The mean
size is about 10µm. extra fine ACH is sometimes
required for ultimate
suspension capability. This grade generally contains 80% minimum less
10µm. and mean particle size of 5µm.
The pH of a 15% ACH solution
is 4.3 compared with 3.9 and 3.5 for a nominal metal/chloride ratio ASC
respectively. Since pH is logarithmic function of acidity/basicity it
that ADC and the lower range of ASC will show more irritation at the
dosage levels as ACH. This is the predominant reason why highly basic
ACH nearly always have an exclusive presence in the marketplace. A
index range for antiperspirant actives relative to their metal/chloride
specifications is shown in Figure 3.
ACH can be polymerically optimized
with higher speaks
3 and 4 to impart a greater efficacy potential over the conventional
These salts may be referred to as enhanced or activated because they
sweat by 30 50% relative to the conventional type. As those experienced
field of antiperspirants have sometimes recognized other formula
not always behave in the same way in the presence of enhanced salts as
with conventional forms. These interactions can impart reheological
the formula as well as diminish the potential difference of the
clinical result. It is the writers contention that some non ionic
particular those with strong emulsifying characteristics will
out the most available coordinated water in anhydrous formulations.
can be found in the lower molecular weight bridged polycations of the
polymer group. Once this bound water is drawn into phase equilibrium
emulsifier migratory movement of the enhanced species to the sweat duct
cleansing creams and lotions
cleansing cream or lotion is the removal of facial makeup surface grime
from the face and throat. A properly formulated cleansing cream or
quickly and efficiently remove such applied cosmetics as face powder
bases cake makeup and lipstick. The large increase in the use of eye
has created a need for cleansing products specially formulated to
adequate washing with soap and soft water will perform the same
cleansing cream has certain advantages. The chemical nature of facial
allows more ready removal by a cleansing cream which is specifically
to dissolve or lift away the greasy binding materials holding pigments
on the skin. Latven investigated the effects of cleansing creams and
products upon a specific type of natural skin oil sebum which had
over the sebaceous or pilosebaceous orifices. These plaques were
resistant to removal by scrubbing with soap and water but they were
the use of various commercial cleansing creams polyethylene glycol 400
olive oils. A series of fat solvents such as acetone chloroform
white gasoline dioxane trichloroethylene and ethanol (95%) although
in removing the surface oil layer were ineffective in removing the
plaques. Latven suggested that the presumed superior efficacy of
creams may lie in their ability to dislodge and remove these plaques
orifices of the sebaceous ducts.
cleansing cream is conveniently
applied and used. Another important consideration is the low irritation
in the use of a cleansing cream. A well balanced modern cleansing cream
leave an emollient residual film on the skin which is protective in a
condition. This property would suggest the avoidance of such a
for oily skins. However it is a common practice with many women to use
cleaning cream first for makeup removal and then to complete the
process by using soap. Cleansing preparations specifically designed for
skin have acquired more importance. These are based on detergent or
or they may be washable. They are designed to remove surface oil and
minimal deposit on the skin.
the primary function of cleaning a multipurpose character can be given
cleansing cream by appropriate formulation. By the addition of
ingredients such properties as the abilities to soften lubricate and
obtained and claimed for some modern cleansing creams.
Blank adequately describe the process of cleaning the skin. Much
reaches the skin. This exogenous soil includes that which reaches the
unintentionally and that which is intentionally applied such as
cosmetics. Autochthonous soils are the products of excretion of the
and apocrine glands. Cells and flakes of the cornfield epithelium are
shed continuously. Both society and health demand that these soils be
from time to time. For the abnormal skin pus blood cells serous
crusts must be removed. Water solvents such as gasoline and turpentine
oil soap and synthetic detergents are agents used for cleaning the skin.
good cleaning agent. In acute or chronic dermatitis a war dressing
serous and purulent exudates and accumulation of crusts. Water removes
soluble soils from the skin. The skin surface normally carries a
electrostatic change. Many particles including bacteria are also
charged. In water these particles are repelled from the skin with
cleansing action. Water alone however is seldom sufficient to clean the
The oily soils on the skin require a solvent or an emulsification
synthetic detergents aid water in emulsifying the oily soils permitting
removal as an emulsion by rinsing with excess water. Solvents such as
and turpentine also remove the oily soils by dissolving them but their
leave the skin deficient in natural oils. Mineral oil has solvent
action on the
oily soils but its use may leave the skin greasy if a film is left
it will leave the skin degreased if it is removed completely with a
cleansing cream is based on the solvent action of mineral oil on the
grease binding either grime or makeup to the skin. The removal of the
of rouge lipstick and face powder from face and throat is a daily
most women. Cleansing cream is an ideal agent to perform this function.
following properties are required of a good cleansing cream
As a cosmetic product it should be
have a good appearance.
It should melt or soften on
application to the
It should spread easily without too
During application it should not feel greasy or oily. After evaporation
water the cream residue should not become viscous.
Its physical action on the skin and
openings should be that of flushing rather than absorption.
A light emollient film should
remain on the
skin after use of the cream.
The directions for use of a
cleansing cream or lotion are standard. The general practice is to
cream to face and throat with fingertips. A rotating upward stroke of
fingers is used to spread the cream. A tissue or soft cloth is then
remove the residue.
In the case of the so called
washable cleansing creams the cream residues may be removed using tap
with or without prior use of tissue.
Most emulsified cleansing
creams can be considered as cold creams modified to enhance their
removing makeup or grime from the face. Physically a cold cream has
body and application than most cleansing creams.
The evolution of the
cleansing cream took place over a period of centuries. The Greek
Galen about A.D. 150 is considered to be the inventor of the first cold
The skin preparations of the ancients consisted of animal and vegetable
and oils. Beeswax and olive oils were used. Galen conceived the idea of
incorporating water into a molten mixture of beeswax and olive oils. In
resulting product the emollient effect of the oil was accelerated and a
pleasant cooling effect was obtained from the evaporation of the water.
process of manufacture was slow and laborious. The product was unstable
subject to development of rancidity. In time sweet almond oil replaced
olive oil of the older formulations and borax was introduced. The
of the borax cut down the time of manufacture and a whiter and more
emulsion resulted. Subsequently spermaceti was added with a resulting
of the product.
Rose water Ointment USP XV shown in
Formula 1 was the
direct descendant of the preceding formulations.
This cold cream was known for many
centuries by the
name of Unguentum or Ceratum Refrigerans. It changed but little in
or method of preparation throughout many centuries. This cream is
absorbed by the skin and produces a feeling of coolness. It has the
disadvantage of being subject to rancidity.
Until around 1900 druggists
compounded such a cream
as needed and stored it in the icebox to inhibit deterioration. The
of such a cream on a commercial scale was not feasible. At about this
cold cream using mineral oil was developed and accepted because of its
stability and other desirable properties.
The Rose Water Ointment USP XV of
Formula 1 although
listed in National Formulary XII is not longer listed in the current
Pharmacopoeia. It had been replaced by Petrolatum Rose Water Ointment
USP XVI which
differs in formula only in the substitution of liquid petrolatum for
expressed almond oil of Formula 1. Subsequently the rose water in this
was eliminated and this ointment is officially listed as cold Cream in
The use of vanishing type creams as
foundation bases and the increase in use of face powder and rouge
War I stimulated the development and sale of cleansing cream which
among the top selling cosmetic products.
Types of Cleansing Cream
Traditionally cleansing creams are
two categories. One is the usual white emulsified or cold cream type
referred to as the beeswax borax type of cream. The other is the
type usually anhydrous in character and consisting of a mixture of
oils and waxes.
As a result of the development of
emulsifying agents many cleansing creams of the emulsion type are made
using either beeswax or borax.
Beeswax Borax Emulsion Type
The beeswax borax emulsion
represents a most
important formulation among cleansing creams. The typical creams are
white of high luster and free from graininess. The creams have a firm
consistency on application to the skin they liquefy and spread with
creams contain a high percentage of mineral oil for cleansing efficacy.
Physically many of these creams belong to the oil in water type of
After the creams are rubbed on the skin sufficient water evaporates to
phase inversion to the water in oil type. With oil as the external
solvent action of the oil for cleansing purposes is facilitated.
In the beeswax borax emulsion type
the minimum basic
ingredients required for a satisfactory product are beeswax mineral oil
water. Other ingredients are normally added to modify or improve the
of the basic formulation. A generally accepted basic preparation (5) is
illustrated by Formula 2.
For intelligent formulation a
knowledge of the
elementary principles involved in the formation of the emulsion of the
properties of the raw materials is essential.
Beeswax is an important factor in
quality of the cream. Beeswax is a raw material of natural origin. For
formulations it is defined as the purified honeycomb of the bee free
other waxes. The chemical composition of beeswax is complex and cannot
expressed by a specific formula. It consists of approximately 71%
esters of wax
acids mainly myricyl palmitate and other myricyl esters 10.5 to 13.5%
hydrocarbons mainly C31H64 C29H60 and
to 14.5% free wax acids referred to as
cerotic and melissic acids 1 to 1.25% free higher alcohols 1%
esters of fatty acids 1 to 2% moisture and mineral impurities
0.3% coloring matter mainly 1 3 dihydroxyflavone.
Its color range is from light
yellow to dark brown and
it is easily bleached either by sunlight or by chemical means. The
range of the material is 62 to 65°C and its acid number is from 17 to
Beeswax does not develop rancidity. It is not a primary irritant or a
sensitizing agent. The commercial beeswax normally used for cleansing
the bleached white grade.
The following are some of the
in the use of various grades of beeswax
with the lowest melting points generally form the softest emulsions.
There is little relation between
number of beeswaxes and the quality of emulsion.
Chemically bleached beeswaxes
least odor in the final product. However there is little difference in
quality of creams made from sun bleached beeswaxes or from chemically
The use of cheaper grades of
beeswax may be
economically unsound since proportionately far larger amounts of the
grades may be required to form an emulsion as compared with standard
There are considerable differences
emulsifying power of various grades of beeswax but these differences at
cannot be explained on the basis of physical or chemical properties.
Once a formula has been
established the quality and source of the beeswax should be
the supplier should be required to deliver equivalent material.
Mineral oil is a hydrocarbon that
is stable inexpensive
not subject to rancidity and odorless. When purchased in accordance
specifications a very uniform product can be obtained. Owing to its
and freedom from rancidity the substitution of mineral oil for the
oils of the older cleansing cream formulations was an important step in
development of cleansing creams meeting consumer acceptance. Mineral
oil is a
good solvent for the oils and greases binding either grime or makeup to
skin. The cleansing power of a cream is related to its mineral oil
Mineral oil also has the advantage of remaining on the skin long enough
allow its mechanical removal by tissue.
Although all viscosity ranges
of mineral oil are used in cosmetic creams the most suitable for
cream are the light and medium viscosity grades. These grades produce a
that does not become viscous on the skin.
In the basic Formula 2 the mineral
oil to water ratio
can be varied widely from 2 1 to 1 2 with satisfactory products being
The higher percentage of mineral oil are related to better cleansing
efficiency. However when the mineral oil content exceeds 60% the creams
sings of instability. Increase of the mineral oil content results in a
stiffening effect on the creams. Increase of water content softens the
results in finer grained and more lustrous creams at the expense of
efficiency. The basic reactions involved in the manufacture of the
borax cleansing cream are the hydrolysis of the borax and subsequent
with the free acids present in beeswax to form the corresponding soaps.
soaps emulsify the mineral oil in the water. Other components of
as myricyl alcohol are considered to have a stabilizing effect on the
The amount of borax used is a critical factor in producing a
cream. The theoretical quantity of borax to be used is the
quantity necessary to neutralize the free acids present in beeswax.
The acid number of beeswax
should range from 17 to 24. Since 1 mg of potassium hydroxide is
3.4mg of borax (Na2B4O7 10H2O) the theoretical quantity
of borax required to react with 1 g of beeswax varies from 57.9 to
formulation purposes 5 to 7% of the weight of beeswax is considered the
amount of borax to be used.
An insufficient quantity of borax
will result in a
dull grainy cream. The emulsion may be unstable and of indeterminate
An excess of borax can cause formation of hard sharp crystals of boric
resulting from limited solubility of the boric acid in the water phase.
The creams represented by Formula 2
can be modified and improved by the addition of other ingredients.
ingredients frequently added to produce variations of the basic
spermaceti cetyl alcohol paraffin petrolatum ozokerite ceresin
vegetable oils cocoa
butter and lanolin.
Since mineral oil may remove
of natural oils from the surface of the skin emollients are often
Spermaceti cetyl alcohol cocoa butter vegetable oils and lanolin serve
Spermaceti in addition to its
emollient effect acts to make the cream more opaque and lighter in
Cetyl alcohol in a proportion of
about 1% acts as
emollient and as an emulsion stabilizer. Cara must be taken not to use
since the cream may soften and become less opaque.
Cocoa butter to the extent of
1 to 2% serves as a skin softener. Higher percentages should not be
a grainy textured cream may result.
Vegetable oils if used should
be in a formula in which at least half of the total oil content is
by a light viscosity mineral oil. Otherwise the cream is apt to be
of poor luster.
A firm cream that has the
property of quick melting on application to the skin is desirable. A
proportion of paraffin will produce this result. Petrolatum will behave
similar fashion but will not harden the cream to the same extent as the
paraffin. Petrolatum will serve to increase the body and help stabilize
cream if a high percentage of oil is used.
Ozokerite and ceresin serve
to stiffen the cream and prevent bleeding of oils when the oil content
Generally when other waxes are
added the amount of
beeswax is corresopndingly lowered. Formulas 3 to 8 represent creams
of the ingredients just mentioned.
The translucent liquefying
anhydrous type of cleansing cream consists of a mixture of oils and
designed to liquefy when gently massaged and to cleanse in the same
the beeswax borax emulsion creams. A physical mixture of mineral oil.
and other waxes is melted mixed and poured while warm. This type of
easier to make but its formulation must be controlled carefully.
the cream is obtained by a thixotropic effect produced by a wax such as
paraffin. The mineral oil to be used must be carefully selected. A
of heavy viscosity produces an oily feel on the skin upon application.
a quantity of crystalline waxes is undesirable because it may result in
separation sweating and a granular appearance. A common difficulty is
formation of a crusty surface. This condition can be corrected by
amorphous materials such as ozokerite and petrolatum for the
The petrolatum also aids in preventing bleeding of the mineral oil
when a light viscosity oil is used.
Emollient ingredients such as
lanolin or its derivatives cetyl alcohol spermaceti and cocoa butter
to leave an oily film on the skin.
The normal cream of this type
is translucent in appearance. A more opaque appearance can be obtained
incorporating such ingredients as zinc oxide titanium dioxide magnesium
stearate zinc stearate or hydrous lanolin. A smoother application is
in such creams with a diminution of the greasy feeling characteristic
class of creams.
2% of zinc oxide titanium dioxide magnesium stearate or zinc stearate
used. These can be incorporated into the product by milling preferably
roller mill. Formulas 9 to 13 are representative of this type of
The liquefying cleansing
creams are used particularly by women with dry skin although many women
oily skins find them effective for degreasing.
Miscellaneous Emulsion Types
Emulsion type cleansing creams
which do not
contain the beeswax borax system can be made using such emulsifiers as
sorbitan fatty acid esters and their polyoxyethylene derivatives
monostearate diethylene glycol monostearate sodium cetyl sulfate and
various absorption bases.
Sorbitan Fatty Acid Ester Emulsions
fatty acid esters and their polyoxyethylene derivatives represent an
series of surface active agents which are being used increasingly in
cleansing cream formulations. They can be used with or without the
borax emulsion system. Both water in oil and oil in water emulsion
types can be
made using these agents. The resulting cleansing creams are stable
manufactured and effective.
increasing sales volume of baby toiletries in the overall cosmetic
indicates their relative importance to the consumer manufacturer
pediatrician. These products include powders oils lotions creams diaper
preparations shampoos and soaps. In 1970 the combined retail sales of
powders oils lotions diaper rash ointments and shampoos amounted to $87
000. Despite the declining number of births from its peak in 1957 the
increase for baby powders in the 1957 1970 intervals was 57.8% for oils
lotions the increase was 77.1% and for baby shampoos the increase was
Part of the increase in baby powders and baby shampoos can be
adult usage. This appears to be due to the focusing of advertisements
in the late 1960 s on the adult as well as the baby market.
growth pattern when viewed in marked contrast to the decreasing births
1957 through 1968 is indicative of the intensive and successful
promotional efforts of manufacturers retailers and pediatricians who
emphasized the need for special products for babies.
birth rates since 1957 is considered by government population experts
temporary. These experts believe that within the decades from 1965 to
from 1975 to 1985 the tremendous birth rate increase that followed the
World War II in 1945 will show up in a new birth rate increase as the
born in the late 1940 s begin raising families of their own.
potential for baby toiletries is indicated in the Census Bureau s
population growth of children under 5. The Census Bureau presented four
principal series of population projections (Series A B C and D) which
user a fairly wide choice of assumptions as to the course of future
changes. The Bureau stated that the uncertainty with respect to future
fertility rates (annual number of births per 1000 women 15 to 44 years
accounts for a fairly wide range in the population projections. The
indicated the Series A and Series D projections are not regarded as
upper and lower limits and that it is even more likely that actual
changes will not follow any particular series very closely.
an interesting and thought provoking discussion of the legal
formula composition function and implied claims for baby toiletries.
considered the relationship between cosmetics and drugs particularly in
toiletries and described a pediatric cosmetic as
which usually contains old components
makes no therapeutic claims is used more or less to prevent rather than
undesirable skin problems and is one which possesses little
action. The spectrum between these extremes is broad and the large gray
the middle emphasizes the difficulty in differentiating sharply between
pediatric cosmetic and the pediatric pharmaceutical. We do know however
formulation can be judged to be a cosmetic or a drug solely on the
its labeling and claims.
the sections to follow we
first discuss epidermal physiology skin care of the newborn care of the
area and care of the hair and scalp. This will be followed by specific
formulations designed to accomplish the desired effects.
We use the term newborn to
refer to the first 2 weeks of life infant (baby) designates children up
end of 1 year and young children include the group from 1 to 4 years of
The skin of the child and
more particularly of the infant and newborn differs from that of the
histologically and physiologically in many fundamental respects. It is
cornified and less hairy. Chemical analysis shows a higher proportion
and of extracellular fluid minerals. The stratum corneum is thin and
its histological structure because the supporting structures (elastic
reticulum) are only partially developed.
In late intrauterine life the
stratum corneum is
thought to be protected by the vernix caseosa from maceration in the
fluid. The vernix is a complex water in oil mixture containing sebum
cells lanugo hair and other debris. The immature fetus has extensive
of vernix whereas the postmature infant has less with distribution
the flexures groin and axillas. Many functions including bacteriostasis
been attributed to the vernix but none convincingly. There is evidence
has a high content of estrogenic substances. It is rubbed off at the
or on the clothing during the first 24 to 48 hours of life leaving
degrees of erythema. Within the first few days of life the erythema
and a fine scaling occurs. There is a tendency toward peeling and
(desquamation) during the first three weeks of life.
After removal or
disintegration of the vernix caseosa the skin is pink soft and silken
touch and very delicate in texture. It is in all likelihood more
substances approaching it from within and without. Al these structural
differences probably influence both the incidence and manifestation of
particular dermatoses in early life.
Sebaceous glands are present
in the newborn and are prominent on the nose cheeks and chin. The sweat
are fully developed anatomically at birth and begin to function very
within a few days after the vernix has gone. At about 3 years of age
component structures of the skin begin to resemble more closely those
adult. Before puberty however the sweat and sebaceous secretions are
Children s hair is on the
average finer rounder less frequently medullated and lighter in color
The transepidermal water loss
of human newborns was studied by Wildnauer and Kennedy and Hey and
Wildnauer reported that the average transepidermal water loss from
skin of newborns in the first 10 days was slightly but significantly
(30%) than that of comparable adult back skin. The mean transepidermal
loss for human newborn upper back skin was found to be 0.18 +
0.06 mg/cm2/hr as compared with 0.27 +
0.04 mg/cm2/hr for the adult.
The effect of relative humidity on
the production and
loss of heat in the newborn baby was evaluated by Hey and co workers.
The skin of infants in
general and of the newborn in particular is highly susceptible to
and infection especially since the immunologic functions are poorly
Potter and Abel reported that few babies display surface sterility at
majority showing contamination principally with Staphylococcus
(formerly called Micrococcus pyogenes var. albus)
coli. In contrast however it has been stated that the skin of
is remarkably sterile for the first 4 to 5 days and that organisms
appear after that. The normal flora of the skin is essentially
it must be regarded as including facultative pathogens for disease of
is produced when the latter is damaged or its defense mechanisms are in
way impaired. Because of its exposed position it is surprising that the
does not suffer more from infection than is the case. However it is
from infection by a number of factors (a) the marked acidity (pH
4 to 6)
of its surface (b) the physical armor of its keratinized layer (c) its
excretory functions and continuous desquamation which tend to remove
microorganisms mechanically and (d) its generally dry surface which
Skin Care of the Newborn
A very important problem in
pediatrics is the proper
care of the skin of the newborn during the stay in the hospital nursery
after reaching home. That there is little unanimity of opinion
largely due to a lack of understanding
of the physiology and pharmacodynamics of the skin of the newborn. The
the newborn s skin during the 4 to 5 days in the nursery has been the
of many research papers characterized by the many variations and
in recommended procedures all of which reflect the ever changing
unanimity was further brought out in a survey of 83 large hospitals on
Practices in the Care of the Newborn . In this report it was noted that
reply to the question concerning the initial bath 5 hospitals reported
no bath 3
bath only after 12 hours 20 that the entire body was cleansed 22 a
the entire body bath and 4 the removal only of obvious soil. In reply
question concerning the solutions used on the skin for this initial
hospitals reported the use of oil 16 soap and water alone 2 water
oil 5 lotion 6 dry technique and 20 a substance not specified. In reply
question concerning the material used for a daily cleansing after the
bath 35 reported the use of plain water 24 the use of oil 18 the use of
and water 10 the use of lotions and the others used various
as alcohol alcohol or oil boric acid cetyl pyridinium chloride 1 1000
ointment pHisohex benzalkonium chloride and only 1 the dry technique.
This multitude of methods of skin
care was even more
striking upon consideration of The Standards and Recommendations for
Care of Newborn Infants published by the Committee on Fetus and Newborn
American Academy of Pediatrics in 1949. In the section on Care of the
The proper care of the skin in the
newborn infant is
important in preventing infection. At present the consensus seems to be
the less manipulation the less danger of infection. It is recommended
water or oil bath be given during the first week or 10 days after
buttocks may be gently wiped away from the folds of the infant s skin
sterile mineral oil on sterile cotton or soft sterile gauze. Each time
diaper is changed sterile oil should be applied to the soiled or wet
The 1971 edition of Standards
for Hospital Care of Newborn Infants stated
Bathing. Blood and excess
vernix caseosa not removed in the delivery room may be removed for
reasons with sterile cotton after the infant arrives in the nursery.
Hexachlorophene bathing reduces the rate of skin and nasal colonization
staphylococci and possibly lowers the incidence of staphylococcal skin
infection in newborn infants. Surgical gauze is not recommended for any
of the routine skin care of the newborn infant because it is more
the infant s skin than cotton.
Care of buttocks. The
buttocks may be satisfactorily cleansed with a cotton ball moistened
warm tap water or a hexachlorophene solution. There should be as little
as possible. If oil is used for the diaper area it should be kept in a
sterile glass container for each infant however it should be recognized
pathogenic organisms may contaminate such containers.
The prevention of epidemics
of impetigo nconatorum has been a major problem in hospital nurseries
years and its complete elimination has not been achieved. It is a
infection due mainly to a Staphylococcus and is
very contagious. Streptococcus
impetigo is encountered at times and is contagious although less so
staphylococcic form. Bullous impetigo is also caused by a
Staphylococcus but is
especially found in newborn babies and infants (often called pemphigus
newborn). Any outbreak of skin infection among newborn in the nursery
in a costly and unpleasant interruption of maternity service and is
difficult to eradicate.
Some of the products and procedures
used in the
nursery to be discussed in greater detail include the following
to five percent ammoniated mercury ointments.
Mineral and vegetable oils
ointments and emulsions.
liver oil ointments.
petrolatum cholesterol emulsion.
or no bath technique where no treatment is given the newborn s skin
seventh day after birth (except for removal of excessive blood with
cotton at birth).
Some researches have emphasized the
from the last method of protecting the newborn s skin by the simple
of chemical and mechanical trauma caused by daily cleansings. This
based on the premise that the vernix caseosa is a necessary covering
serves as a lubricant for the baby s skin. While it has been considered
barrier against bacterial infection Lubinski and Benjamin demonstrated
inability of the vernix to protect against staphylococci or E.
vitro. Sprunt and Redman also demonstrated that vernix
caseosa tested in
vivo and in vitro showed no evidence of
Removal of this covering has been shown to be unnecessary and Apfel has
recommended that it be preserved. After it has served its purpose it
dissolve at normal body temperature absorb or dry up then fall off
within a few
days if left undisturbed. By leaving it intact microscopic abrasions
in the superficial layers of the skin and contamination incident to its
are avoided. But if desired by the doctor the larger masses of vernix
wiped away with sterile cotton dipped in sterile vegetable or mineral
In the group of external
antiseptic applications the preparation most commonly used was
mercury ointment in varying strengths (1 to 5%) selected because of its
value in the treatment of impetigo. Fischer pointed out that this
possessed several recognized disadvantages. It involved a time
technique at least one and frequently several complete inunctions
neonatal period being required. There was always the not inconsiderable
of sensitivity reactions and even possible nephritic damage. The
evidence clearly indicated that complete protection was lacking.
Another method in the prevention
and treatment of
skin infection of the newborn is the use of various sulfonamide
Fischer maintained that this method possesses the same disadvantage as
of ammoniated mercury or other ointments plus the very real danger of
reactions and sulfonamide sensitization . In contrast to this viewpoint
are the excellent results reported by Weymuller and Ittner with a 5%
sulfathiazole ointment in an oil in water emulsion base. No instance of
sensitization to sulfonamide compounds was encountered in 3205 newborn
Another comparative study
reported by Heimer and co workers was on the treatment of alternate
infants with local applications of sterile mineral oil or a cod liver
ointment. There was an incidence rate of 1.35% of rashes in the mineral
group and 0.85% in the cod liver oil ointment group. A subsequent study
same authors indicated that a cod liver oil ointment and cod liver oil
were effective in the topical treatment of several skin disorders
contact dermatitis (due to diaper rash) and chafing in opposing skin
and co workers recommended the use of cod liver oil ointment for
intertrigo (diaper rash) because of the rapidity of its healing action.
and Marks found the cod liver oil ointment to be effective in the
proctological disorders. All of these cod liver oil ointments and
based on Norivegian cod liver oil lanolin petrolatum zinc oxide and
stated that absorption of both vitamins A and D is known to take place
abraded areas. The saturated and unsaturated fatty acids in the oil
an unknown part in maintaining the reparative process. The physiologic
of cod liver oil appears to be primarily to promote anabolic action.
During the 7 to 10 days in the
nursery care of the
diaper area varies tap water sterile water baby oil or lotion being
the removal of fecal soil. Skin folds are cleansed with water oil
are left alone. There are several references in the literature to the
use of antiseptic
oils . These preparation are based
on mineral oil and vegetable oils (peanut sesame olive cottonseed) used
separately or in admixture. Some oils contain hexachlorophene as the
and an antioxidant (tocopherol or butylated hydroxyanisole) to retard
development of rancidity of the vegetable oils. Fischer stated that
use of these antiseptic oils there still exists the disadvantage of
irritation sensitivity reactions and only partial protection.
Antiseptic baby oils are far less
ammoniated mercury ointment and have enjoyed wide usage for many years.
the Committee on Fetus and New born of the American Academy of
recommended the use of oil for wiping the folds of the infant s skin in
buttocks area with application of stertile oil to the skin at each
change. Holt and McIntosh recommended
During the first few days of life
the newborn may be
cleaned with oil and cotton the full bath being deferred until after
has separated. After the bath the skin of most infants requires nothing
than careful drying others particularly very fat infants benefit by the
application of a small amount of oil or lanolin or by some bland
powder in the folds of the skin. If plain water produces an undue
irritation salt may be added to the bath water to bring it to the
concentration of physiologic saline.
An opposing point of view
the use of oils applied to the newborn skin during the first weeks of
expressed in 1951 at a Round. Wrong stated that oils coat the skin and
the glands in that way. He continued
If there are organisms in the
area there is more tendency for them to invade the oil and sweat
glands. Oils which
contain perfume and various antiseptics may act as sensitizers and
eruption. The tendency in the past has been to overdo the use of skin
new born s skin is better if it is cleaned with plain water and if soap
sparingly certainly the skin should not be covered with grease or oil
contain some perfume or substance which will in itself be a sensitizer.
At the same symposium on
Pediatric Dermatology Ross stated
In newborn infants
overzealous cleaning of the baby and too much anxiety on the part of
following birth are apt to do far more harm than good. Antibacterial
preparations are not to be used often and probably are not advisable.
Up to 4
or 5 days the skin of the newborn is remarkably sterile and organisms
begin to appear
after that. There are a number of institutions that have substituted a
regime of leaving the vernix on for a period of from 2 to 5 days then
removing this material with lukewarm water and no use of soap what
ever. For a
period of 3 or 4 weeks at home no soap should touch the baby s skin
is used later it should be a super fatted soap and the child should be
not more than 2 times a week. The horny layer on a newborn baby s skin
exceedingly thin and is very sensitive to the alkaline soap. Since
alkali has a
marked effect on a newborn baby s skin the use of soap in the early
life should be stopped.
Again concerning the
contraindications of soaps and oils Gaul and Underwood stated
Overcare of the skin… produces a
high incidence of
minor rashes and irritations. A good example is the care of the newborn
The daily soap bath defats the skin causing erythema dryness roughness
disturbance in keratogenesis subthreshold vascular injury. A baby oil
for the natural skin lipids. It further dissolves out the lipids that
and water missed. This overcare perpetuates the pinkness of the newborn
and accentuates dryness and redness. Minute fissuring and chafing of
epidermis is the result. The skin that has had overcare is susceptible
rashes and secondary infections and weather changes to lower
humidities stress the vascular bed to the point of eczematization. The
result of overcare is that the skin is less able to withstand the
exigencies of weather changes.
In Apfel s opinion the
occasional occurrence of skin infection in the newborn in spite of
application of antiseptic oils is due to the fact that it is difficult
injure the baby s skin in the act of massaging it with the oil and
the skin is never quite sterile the break of the superficial layer of
is an invitation for the bacteria to bring about impetigo.
masklike effect in ancient times to the natural look which has
the current decade face powders have been and still remain one of the
the cosmetic industry.
powder fashions during the last twenty five years have far surpassed
in any previous period of time. The matt (dull) look in makeup is passé
natural look shows no sign of waning. Transparency is the word a woman
skin should show through. Tinted shiny enhanced by our modern cosmetics
woman of today is able with only modest effort to be more attractive
has ever been in the past.
transformations in fashion have evolved modifications in the
manufacture of face powder. Contemporary concepts of makeup and the
diversity of products have brought with them numerous technical
It is hoped
this chapter will present guidelines that will be helpful in the
good present day face powders.
face powder is basically a
cosmetic product which has as its prime function the ability to
color by imparting a velvetlike finish. It should enhance the
appearance of the
skin by masking the shine due to the secretion of the sebaceous and
glands. A powder should achieve its effect by being opaque enough to
blemishes but it must not impart a masklike effect. In addition the
posses reasonable lasting properties so that frequent repowdering is
no one ingredient that possesses all the properties desired in a face
blend of constituents is employed which imparts the following essential
characteristics of a good product
power. The ability to
mask skin defects such as skin shine enlarged pores and minor blemishes.
faculty of spreading over the
skin without dragging and the characteristic smooth feeling.
The ability to
cling to the face.
The capability of
absorbing skin secretions (perspiration oillness) without showing
evidence of such
The ability to impart a
velvety peachlike finish to the skin.
LOOSE FACE POWDER
The primary consideration in
the manufacture of face powder is the selection of the raw materials.
spectrum of basic ingredients used is rather narrow thus the quality of
all the more important since it will it s a most significant role in
ultimate powder formulation.
A face powder must be a blend
of specific raw materials if it is to be a product which exhibits the
characteristics desired. Therefore would be well to list the basic
normally employed as well as the properties each may impart to the
The first and foremost
ingredient to be considered in the formulation and manufacture of face
is talc. The variety of talcs which are available is ostensive.
Chemically talc is a
magnesium silicate (3Mg O.4SiO2. H2 O)
. It is a basic ingredient of
virtually all modern face powder formulations. Its outstanding
easy spreadability (slip) and low covering power.
Talc is the softest material
on the Mohs scale of hardness and should be judged on the basis of slip
fineness grit density color and odor. For face powder use talc should
and virtually odorless with a smooth greasy feel. Of course excellent
properties are the fundamental necessary.
The highest quality talcs
have been mined in France and Italy a great deal of talc is now
the United States. Proper grading by the producer will greatly
final quality of the talc.
Particle size of a talc is
one of the criteria for its standard of quality. At least 98% should
through a 200 mesh screen (no larger than 74µ) micronized talcs are now
available in which the particle size may be reduced to several microns.
of micronized talc is desirable in cases where an even particles size
bulking value is required. Bulk density (degree of fluffiness) is of
importance in talc since variations will greatly affect the quality and
packaging of the final product.
The proper selection of
micron size is very much dependent on the type of face powder desired.
talc will not adhere to the skin as well as one that is considerably
may result in abrasiveness on powder application. On the other hand the
fineness of talc may reach the stage where the material may lose some
basic structure and characteristics. Certain talc possess a
attainable with any other face powder constituent and if the particles
talcs are too finely divided they scatter light and appear to be of
opacity. Thus excessive division of particles may result in the
valuable properties of a talc.
is an innocuous material.
Kaolin or China clay is a
generic term which is applied to several hydrated aluminum silicates.
a naturally mined product derived from feldspar it excels as a face
adjunct. It possesses good covering power and adhesion as well as
grease resistant and perspiration absorbent properties. Kaolin helps to
the shine of talc and has certain soothing effects on the skin. Since
it is a
compound of high density it is used in formulations to adjust
The color of the kaolin used
should be as light as possible (slightly off white to pale cream
raw material should be highly purified to entirely remove gritty
All aluminum silicates cannot
be classified as kaolin. There are however three distinct groups of
have essentially the same formula (AlO2O3.2SiO2.2H2O) and may be called kaolin nacrite
dickite and kaolinite.
Since kaolin is hygroscopic its
use in face powders does not normally exceed 25% (more may result in
during damp weather).
Kaolin like talc is a
Precipitated Chalk (Calcium
In face powder formulation and
manufacture a good
cosmetic grade of precipitated chalk which is not used in excess serves
preserve a certain balance between slip and adhesion covering power and
A grit free calcium carbonate
reduces the shine of
talc and has good covering power. It helps to absorb the perfume and is
grease resistant and perspiration absorbent. Precipitated chalk is also
excellent for developing the bloom effect when face powder is applied.
Precipitated chalk is a mildly
alkaline white odorless
microcrystalline powder it is quite dull and has a chalky feeling. When
raw material is used in excess the powder may acquire a dry feel but
usage is most helpful to face powder formulas.
The valuable characteristics of
make it a commonly ingredient in face powder. Magnesium carbonate has
absorbent properties and has been proven satisfactory as a means of
distributing perfume. Its density is a fraction of that of precipitated
carbonate quality which may contribute to the development of a fluffy
The magnesium carbonate used should
be of as fine a
quality as possible and free from contamination by impurities. As in
of calcium carbonate magnesium carbonate should be employed in
use in excess may result in a drying effect on the skin.
Zinc and magnesium stearates are by
far the most
widely used of the metallic stearates. For face powder the stearates
must be of
the highest quality to avoid the development of rancid disagreeable
The most important characteristics
of zinc and
magnesium stearates are their adhesive and waterproofing properties.
stearate the most commonly employed also possesses a soothing quality.
Used in excess stearates may create
a smeared blotchy
effect on the skin. In moderate amounts (4 to 15%) however zinc
particular contributes to the adherent qualities of a face powder.
Zinc Oxide Titanium Dioxide
Since one of the primary functions
of a face powder
is to mask minor skin blemishes covering power must receive careful
There are two basic opacifiers
employed in face
powder formulas zinc oxide and titanium dioxide. Too much coverage by
may produce a masklike effect which is undesirable too little gives a
with insufficient body.
It is well known that zinc
oxide has certain therapeutic properties and helps to clear up minor
disorders. However excessive use of this material may result in a
Zinc oxide possesses moderate
adhesive properties and is comparatively inert. When employed in face
should be of high quality as white in color as possible odorless
and free from grit. To avoid any drying effect and yet allow for
coverage a formulation may consist of as much as 25% zinc oxide. In
face powders however such a high proportion of this opacifier is seldom
Titanium dioxide is three to
four times better as a covering agent than zinc oxide but it has less
and does not blend quite as well. For a face powder in which an
quantity of covering power is desirable the judicious use of titanium
oxide or a blend of the two is necessary. Variations in the properties
titanium dioxide and zinc oxide allow for fluctuation in talc and other
ingredients of the formulation which change all of the basic
a face powder.
Used alone or in conjunction
with zinc oxide 10 to 15% titanium dioxide will allow for sufficient
in any powder formulation.
Several decades ago the use
of rice starch as a basic ingredient in face powder was widespread its
activity is limited.
The use of rice starch has
brought into play bacterial decomposition problems since it is an ideal
nutrient for bacteria. The bloom and absorbent properties that were
by the use of rice starch are now provided by calcium carbonate and
materials in face powder formulas.
Silicas and Silicates
Silicas and silicates may be
found useful in face powder to maintain free flowing characteristics
high humidity. Silicates have also been employed as perfume carriers.
The use of fine silicates such
as magnesium trisilicate is helpful in face powders since they have
high water and oil absorption properties.
Frosted. Look Materials
In face powder as in all
modern cosmetics the use of materials to give a frosted appearance has
much come into vogue. This trend to the translucent and shiny look has
to the widespread use of raw materials which help create this effect.
For a number of years natural
pearlessence (guanine) served the cosmetic industry well. Guanine
needlelike colorless and transparent crystals which by the simultaneous
reflection and transmission of incident light on their platelets impart
luster. Pearlessence exhibits extreme light stability.
Due to its cost uncertain
supply and inherent natural characteristics guanine could not be
certain uses in the cosmetics and toiletry field.
The synthetic pigment bismuth
oxychloride was developed to replace guanine. Although photosensitive
oxychloride is quite adaptable for use in frosted face powders to
metallic pearl like luster.
Metallic powders (mica aluminum
bronze) are widely used to formulate powders with a sheen. Since these
reflect all rather than a portion of the incident light the luster is
than that produced by the pearl. However the cost is very much lower
synthetic pearl and these metals may be judiciously blended with
oxychloride to create fine pearly looking face powders.
Mother pearl (thin layers of
calcium carbonate which are bound together) has also been found useful
powders to produce the frosted effect. It should be noted that
synthetic pearl mother
of pearl and mica must not be milled since milling would destroy their
The use of color additives is
basic to the art of creating face powder which display the subtle
shading required for the discriminating female population. The colors
invariably employed are either the inorganic pigments or the organic
toners. Since there is a possibility of color bleed due to their
by perspiration and fatty secretions the water or oil soluble dyes are
to any degree. Under the provisions of the Federal Food Drug and
Cosmetic Act the
organic color additives must be government certified inorganic pigment
do not require
The quantity of color required
depends to a great
degree on the type of base used in the formula. The opacity of the
transparency of the talc greatly influence the quality of color needed.
There are a
large variety of synthetic iron oxides available for use in face powder
manufacture. The natural oxides such as umbers siennas and ochres like
synthetic iron oxides are in themselves of a dull nature and the coal
colors are often needed to add brilliance to their color tones. The use
quality inorganics blended with a smattering of organic lakes allows
broad variety of face powder shades the number of colors employed must
be kept to a minimum.
It must be remembered that
lakes do have varying degrees of instability to light a factor not
with the use of inorganic pigments. The light fastness of a lake
be carefully considered since it does play an important part in a
The added brilliance of lakes makes them indispensible to the
the inorganic pigments.
In passing it would be well
to stress the importance of color grinding to bring out maximum shade
development. Poor pulverization of color extenders will result in
underdevelopment of shade intensities and in tones that differ from
obtained by efficient pulverization. To bring out the maximum color in
batch of a face powder the pigments used must be of uniform particle
The selection of the proper perfume
and its most
efficient manner of dispersion within the face powder is of extreme
the odor of a powder plays an important role in the sales potential of
product. Proper dispersion of the perfume is not a simple procedure
the extremely large surface area of the cake and the possibility of
the perfume with impurities in the raw materials employed. If the raw
are of a fine cosmetic grade the fragrance selected will be that much
less of a
problem in the finished face powder formulation.
It is of vital importance that the
perfume used be
nonirritating stable to mildly alkaline conditions and that it not
oxidation or volatalize too easily. The fragrance must be compatible
of the powder ingredients since problems with rancidity heterogeneity
of odor and
discoloration may result from improper odor selection.
The concentration of the
perfume in the product is variable but if this concentration is too low
not be perceptible and will not properly mask raw material odors. On
hand too high a perfume concentration may result in an overpowering
odor and it
may cause lumping of the powder. It may also cause skin irritation. As
a rule between
0.2 and 1.0% is a reasonable of perfume range in a face powder.
The manner of introducing the
fragrance in the face powder can be varied. The fragrance may be mixed
of the raw materials which has good absorbent powers (magnesium
it may be sprayed into the entire batch. In either case it is of
that the perfume be homogeneously dispersed in the face powder.
Odor selection is at best
subjective and based on the
olfactory characteristics desired by the manufacturer. The fragrance
undergo scientific scrutiny and tests should be run to determine that
actually compatible with the particular powder formulation. Perfume
manufacturers can help and advise in any problems that arise with the
In summary the basic ingredients
covered and their
associated outstanding characteristics are listed in Table 1.
A face powder is as dependent on
the quality of the
raw materials as it is on the skill of the formulator and the
procedures outlined. There can be no compromise on ingredient quality
superior face powder is to be ensured.
A face powder formula should
be adapted to the characteristics desired and the type of skin to be
In general the skin to be powdered will fall into three categories dry
or moderately oily and very oily.
On the basis of these skin
variables loose face powders have been classified as light medium and
These designations do not refer to the density of the powder but rather
quantity of powder necessary to cover the same area of the skin the
Since a dry skin will secrete
virtually no oil and little moisture it requires a powder of slight
power a light powder. Normal or moderately oily skins which are shinier
skin secretions require a somewhat higher coverage a medium powder.
oily skins which have a great deal of shine require great covering
power a heavy
powder. Formulas 1 to 9 represent the various types of loose face
The quantity of perfume to be
incorporated in a formula will be based upon the aesthetics of
characteristics and the intensity of odor desired. Generally 0.5% would
satisfactory starting point for the evaluation of a perfume in a powder
The amount of pigment to be
employed will depend on the shade opacity and color intensity of the
be manufactured. Pigments in the form of dilutions may vary from the 1%
to the 5% range in the finished product.
COMPACT FACE POWDER
Compact face powder which was
introduced in America
in the 1930 s has surged in popularity due to its extreme ease of
and storage convenience. A compact powder is a dry powder which has
compressed into a cake and is usually applied with a powder puff.
shaving preparations soap creams oils and lotions
The origin of
shaving that is some form of cutting the hair on and about the face
predates recorded history. One of the earliest records attesting to the
existence of barbers is mention of them in the Bible and some have been
back as early as 400 B.C. in Greece Shaving soaps or aids as such were
described over 125 year ago and as would be supposed were prepared by
saponification of cooking fats with potash and soda lye. Since these
attempts man has been trying to make this process of shaving a more
and comfortable necessary ritual.
The total shaving cream
market has been constantly growing because of an ever expanding
also especially in the last decade a vastly growing awareness of
appearance as evidenced by the fact that more American men are shaving
frequently now than they did in the last century.
Even though many men look
upon shaving as a chore and at best a necessary evil they are rather
about the shaving preparation they will use. Although some men have
preferences and will use only one brand or type of shaving soap or
are willing to try another product or type of preparation if it can
advantages such as greater speed or more comfort. This can be seen by
evolution of various types of products offered by manufacturers and the
that they are constantly working to improve their existing products and
new ones which will appeal to or satisfy the shaving male.
Preferences in shaving
preparations have undergone definite changes. For the longest time soap
dominated the market first in the form of the cake or bar then in the
or powdered form. These in turn gave way to the cream type products
and brushless. Again these products encountered competition from the
of the dry electric shavers with their claimed advantage over the old
wet methods. Then the advent of the aerosol age and the aerosol shaving
caused another change in men s shaving preferences one that to this day
accounts for the majority of shaving preparation sales.
In the year 1965 aerosol
shaving cream accounted for over one half (57%) of all shaving cream
the United States. By 1966 this figure was increased to almost two
(65%). Interestingly the profile of users shows that convenience was
biggest factor in the growth of aerosols and that the greatest users of
brushless and lather type of products were mostly men in the age
bracket of 45
Regardless of the type of
product chosen most must possess certain attributes which will make
necessary and salable. Some of the more important properties of shaving
preparations are the easy and rapid production of a copious lather
to rapid drying or collapse while on the face during the normal length
needed for shaving freedom from the possibility of causing skin
to the mucosa of the eyes nose etc. rapid softening of the beard and
viscosity to hold the hairs erect to facilitate cutting the individual
lubrication to make the razor glide over the face more easily and
Also as with any consumer product the stability of the preparation must
adequate at all temperatures corresponding to all possible geographical
where one might be expected to use it. These preparations should not
rusting or dulling of razor blades although with the advent of the
steel blades this is no longer as important a consideration.
The evaluation and testing
for many of these criteria are largely subjective and ultimately rest
user and shaver. However some researchers have attempted to devise
evaluation. Hair softening studies were conducted by Valko and Barnett
Hollander and Casselman. These were primarily measurements of the
hair by water and its effect on the softening or cutting strength.
and Casselman determined that with the use of 120°F water for pre
beard a minimum of 2 ½ to 3 min would be needed to attain satisfactory
softening prior to shaving. This preparation time increased with a
Ross and Miles devised an
apparatus and published a method for measuring the foaming capabilities
soaps and detergents and Scott and Thompson were able to measure the
consistency or viscosity of foams.
Many shavers have found that the
passage of the razor
edge across the face was invariably accompanied by the production of
superficial cutaneous abrasion of the skin. These abrasions more often
were invisible but resulted in subsequent irritation. A study of the
trauma caused by shaving was made by careful examination of the
residues obtained from the faces of men who had shaved. The skin
found to be composed of hair with large amounts of varied epithelial
both nucleated and non nucleated. This localized trauma could be
the factors that tend to promote a closer shave. These factors would be
of sharp new blade the use of thin lathers or plain water excessive
of the skin or the raising of the hair follicles as after the use of a
pilomotor agent or shortened preparation times. It is to prevent or at
reduce this trauma that the use of thicker lathers is preferable and
emollients lubricants and other additives are added to most shaving
Shaving Soaps Sticks and Powders
Shaving soaps originally were
prepared in bar or cake
form then in the shaped mug or bowl form. They all had to be applied
shaving brush to produce a sufficient quantity of lather. Although the
shaving soap may appear physically to resemble some ordinary bar toilet
are changes that must be made in the formulation in order to meet the
requirements of a shaving soap.
A shaving soap must lather quickly
and copiously which
is a property of the coconut oil soaps. However the lather must be
dense in texture and reasonably long lasting which is more
the fatty acid soaps of palm oil or tallow derivation. Soaps of this
group lather more slowly than the coconut soaps but have better
properties and so some combination will usually give a better product
the soap of any single fatty acid or oil alone. The ease of lathering
depends on the solubility of the soaps and potassium soaps in general
soluble than the corresponding sodium soaps. Nevertheless potassium
are usually softer and a certain proportion of sodium soap must be
give body to the mixture. In addition various soaps have different
for causing irritation. Emery and Edwards conducted a study based on
production of pure soaps and the use of patch testing and classified
their order of irritancy. Emery and Edwards concluded that in general
potassium soaps are more capable of producing irritation than are the
soaps but that the differences may not be due to alkalis alone but also
associated with solubility double bonds and pH.
Many additives and modifications
have been suggested
to improve upon the basic soap type of system. Doran has suggested the
use of triple
pressed stearic acid in place of tallow provided it is used in
a vegetable oil to enhance lathering. Myers on the other hand claims
that a 70
30 mixture of palmitic/stearic soaps instead of coconut oil soap is
irritating and lathers as well. German patent 421 490 claims the use of
superfatting agents for soap of the type of monodecyl dodecyl
hexadecyl ethers of diglycerol amines such as dodecyl ( dihydroxy
amine. Albumen decomposition products of high molecular weight such as
lysalbinic acid and protalbinic acid acylated at the nitrogen with
acids of carbon length 12 to 18 are claimed to aid in lime soap
also to help retain moisture in the lather thereby retarding dry out.
claims that alginic acid or its salts of potassium or sodium added to
soap at 0.1 to 20% will soften the fatty material or oils in the hair
than soap and because of their high viscosity will create in
soap a firm lasting foam.
Styptic or hemostatic materials
such as the lipid
soluble fraction of soybeans and adrenalin and its salts have been
into shaving soaps so that they give the shaving preparation a mild
action which is sufficient to prevent or stop bleeding caused by
cutting by the razor blade. Also the addition of 10 to 15% talc is said
increase the persistence of the lather and reduce the danger of
cutting by aiding the razor to glide over the face more readily than
ordinary shaving soap is used. In 1937 before the advent of the
razor blade a United States patent recommended as an additive to
oxidizing compounds such as chromic acid chromates dichromates
and perborates. The purpose was to produce a passive condition of the
steel of the blade so that the blade would efficiently resist corrosion
prolonging its usefulness through more shaves.
In order to obtain closer cleaner
appearing shaves the
use of pilomotor agents has been suggested. These materials when
applied to the
skin in concentration of 0.1 to 10% are supposed to cause contraction
hair follicle muscle (arrectus pilorum) thereby
projecting the hair
fiber further out of the follicle by about 0.2 to 0.3 mm. If the beard
shaved off while in the extended position the hair stub will withdraw
into the skin after relaxation of the muscle and give a cleaner
Several patents for alkali stable materials have been granted. These
the types 2 (phenyl amino) 1 3 diazocyclopentene (2) such as 2 (2 6 dichlorophenyl)
amino diazocyclopentene (2) 2
morpholine and its
acid addition salts and 2 aminoimidazolines and its salts such as 2
Shaving sticks are usually
produced in a very dry firm form which is rubbed onto the moistened
worked into a lather with a brush. This product is not significantly
from the bar shaving soap and is much like the mug or bowl soap.
An example of a shaving stick
is Formula 2.
These products usually
possess only small amounts of glycerol are composed mainly of stearic
contain larger percentages of potassium stearate than the bar soaps.
nonsoap containing non lathering shave stick was patented in 1939. This
was to be applied directly to the moistened skin at which time oxygen
released from an alkali peroxide such as magnesium peroxide. This
claimed to be capable of conditioning the beard for shaving by its
ability in the decomposition or dissolution of the hair substance.
This type of product is
relatively unknown now but at one time was popular with barbers. This
because the powder could easily be dispensed into a shaving mug prior
addition of water and the production of a lather using a shaving brush.
product was also more sanitary in that a fresh quantity of powder was
each application. A typical product of this type is Formula 3.
Essentially a lather type
shaving cream contains ingredients similar to those of the bar shaving
However because of the inclusion of a greater amount of water and the
pasty consistency desired this type of product is subject to all of the
stability problems associated with bar soaps and in addition the
viscosity stability and product separation.
As with the bar soap the type
of fatty acids and their ratio as both the potassium and sodium soap
affect the foam which is subsequently produced. In the lather creams
ratio affect not only the foam qualities but the consistency and
well. Small changes in these ratios can greatly change the viscosity or
consistency of a cream. Sodium soaps for example tend to product a
firmer cream and potassium gives a cream that is softer and better
but possibly not as stable. Here it is for the formulator to decide
qualities are most important to the product he wishes to make. A
starting formula can be found in Formula 4.
The addition of borax in
minor amounts of 0.1 to 1.0% has been found to have a marked effect on
viscosity of the creams and is sometimes employed for this purpose.
ingredients can be added to the lather cream to help improve the lather
the face feel better retain moisture or make the lather more
creams contain super fatting agents which serve a twofold purpose first
neutralize any free alkali that might be present and second to help
both the cream and the lather. The most common super fatting agents are
stearic acid free coconut oils or other vegetable oils mineral oil or
However lanolin or its derivatives are normally used in lesser amounts
their emollient properties. Significant quantities of glycerol (5 to
usually used to help keep the cream soft and pliable and improve the
retaining moisture. Propylene glycol or sorbitol may be substituted for
glycerol if it is preferred. Menthol is sometimes added for the
cooling effect it imparts or because the odor is preferred by some men.
Hexachlorophene has been added by some manufacturers for its
contribution as a
germicide. Triethanol amine is usually avoided in lather creams because
often discolor with age and upon hydrolysis can produce ammonia.
The use of fractionated acids from
coconut or palm
kernel oil has been claimed to make nonirritating soaps with good
properties. The soap of almost completely hydrogenated vegetable oils
oils (such as cottonseed peanut soybean sesame corn sunflower olive and
linseed) and tallow lard oleo etc. have been recommended for their
high temperature stability in preference to soaps made with commercial
acid or unhydrogenated oils. As mentioned previously alkali stable
agents such as derivatives of 2 aminoimidazoline have also been
lather creams. Since many lather creams today are packaged in
aluminium tubes 0.1 to 0.4% sodium silicate can be added to prevent
The brushless shaving cream
resembles lather shaving
cream in appearance. There the similarity ends. Whereas the lather
cream is a
soap which is intended to produce foam the brushless cream s purpose is
produce a foam. Brushless shaving creams are in essence oil in water
of the vanishing cream type. The possess certain possible advantages
shaving soaps such a greater convenience and speed since they do not
brush for application and they give a more comfortable shave because of
greater lubricating ability and subsequent reduction in razor pull or
They also leave the face with a thin coating of oil or grease after
makes the skin feel less irritated and softer.
Since the brushless creams do not
contain any major
amounts of soap they do not of themselves soften the beard and this
must be accomplished by first washing the beard with soap and water
application of the cream. The brushless cream does keep the hairs of
erect retains moisture well and above all provides a maximum of
between the razor blade and the skin.
A simple starting formula for the
manufacture of a
brushless shaving cream is found in Formula 5.
may be incorporated to improve upon the product s consistency lubricity
ability or feel. Borax in concentrations of 0.1 to 0.5% may be used to
consistency or viscosity. Humectants such as glycerol propylene glycol
sorbitol may be used for their moisturizing ability and their effect on
softening the cream. Emollients such as lanolin and its derivatives or
alcohols such as cetyl alcohol may be added for the unique feel that
impart to the skin. The use of various wetting agents such as the
aromatic hydrocarbons sulphuric acid esters of lauryl alcohol fatty
and phosphatides such as lecithin has been suggested to increase beard
softening. Gums such as methylcellulose tragacanth alginates and
have been suggested. These materials add stiffness or body to the cream
moisture and possibly provide more slip to the face.
Oils and Lotions
Another class of shaving
preparations has existed which is neither soap nor brushless cream in
classical sense. These products are various compositions of oils and
are applied before another shaving preparation as a pretreatment or may
alone for the purpose of shaving with a razor blade. Some are merely
to improve the shave by performing the function of beard softening. One
earliest of this type was patented in 1927 and suggested the use of a
of sugar borax turpentine and water for treating the beard prior to the
application of a shaving soap. A more up to date version of this is one
upon a 0.5% solution of a polyoxyalkylene derivative of sorbitan
products have been claimed which depend on gums or other mucilaginous
substances to provide additional lubrication on the skin other than
obtained with the regular soap type shaving preparations. These
intended to act as primary lubricants usually in combination with
such as surfactants mineral oil and lanolin derivatives. The most often
employed have been starch and gelatin sodium carboxymethyl cellulose
and acrylates and alkyl cellulose ethers as in Formula 7.