Decoding the Cosmetic Label

by Judith E. Foulke

     How can you be sure your shampoo that claims to have all natural
ingredients does not also contain some synthetic chemicals? Or that your hand
lotion actually does contain the vitamin E it claims? The logical response
should be, "Read the ingredient label on the back of the product." Logical, if
you happen to be a chemist or a cosmetic scientist. Perplexing, if you are the
average cosmetic consumer.
     A quick glance at the back of the cosmetic label is all it takes to see
that the ingredients are written in the language of chemistry. (See
accompanying article.) Unless you know that one of the shampoo ingredients--
methyl paraben--is a synthetic preservative derived from a petroleum base, or
that tocopherol is vitamin E, you may never be able to check the claims
against the contents.
     John Bailey, Ph.D., director of the Food and Drug Administration's
Office of Cosmetics and Colors, understands such consumer dilemmas. He and the
scientists on his staff admit that most of us don't recognize the names of the
ingredients listed. But there's no way to change that and still accurately
identify the ingredients.
     Chemical names are the only way ingredients can be listed because that's
what they are. Most are cosmetic formulations, but in some products, such as
an underarm deodorant that also claims to stop perspiration, the first
chemical listed may be a drug ingredient and FDA would classify the product as
a drug as well as a cosmetic.
     Many ingredients are marketed with trade names, but these often provide
little clue to the identity and intended use of the material. Trade names in
the ingredient list could be confusing to consumers purchasing a cosmetic
because they would have no way to compare similar ingredients in similar
products. Also, some trade names include mixtures of raw materials--for
example, an ingredient could be combined with a preservative.
     Despite the highly technical language of the ingredient list, Bailey
says it's entirely possible for consumers to get valuable information about a
product by checking the label--front and back. To decode the cosmetic label,
here's what you need to know.

Image vs. Reality
     Don't be fooled by claims made for certain cosmetic ingredients. Their
presence in the products could be pure puffery because the law does not
require cosmetic manufacturers to substantiate performance claims.
     "Image is what the cosmetic industry sells through its products," Bailey
says, "and it's up to the consumer to believe it or not." (See "Cosmetic
Ingredients: Understanding the Puffery" in the May 1992 FDA Consumer.)
     FDA considers the labeling of vitamins in cosmetics a separate issue,
however, and does not recognize health claims for them in cosmetics. A product
that features a vitamin--for example, vitamin E--must list it by its chemical
name--tocopherol--on the ingredient list. Listing it as a vitamin in the
ingredient statement would give the misleading impression that vitamin E in
the product offers a  nutrient or health benefit. (Vitamin E is usually added
as an antioxidant to prevent chemical deterioration of the product.)
     Consumers can get important health and value information by checking the
ingredient list. For example, if you need fragrance-free hair spray because
you have a sensitivity, a product containing a fragrance--even one that just
masks the chemical odors of the raw materials--could be a waste of money if
you can't use it.
     Ingredient statements on cosmetics were first required in 1973 under the
Fair Packaging and Labeling Act, enforced by FDA. Before then, consumers could
only guess what was in a cosmetic product or if the product contained what it
claimed. That requirement is especially valuable today with the industry
competition for new ingredients.
     The law allows a manufacturer to ask FDA to grant "trade secret" status
for a particular ingredient. FDA grants this status under very limited
circumstances and after careful review of the manufacturer's data. The
manufacturer must prove that the ingredient imparts some unique property to a
product and that the ingredient is not well-known in the industry. If trade
secret status is granted, the ingredient does not have to be listed on the
label, but the list must end with the phrase "and other ingredients."
     Consumers can also check value by comparing ingredient lists of similar
products. Ingredients are listed in descending order, starting with the
greatest amount in the product. A lotion with a featured ingredient close to
the beginning of the list, for example, would have more of that ingredient
than any other ingredient. A featured ingredient listed close to the end
suggests that not much of that ingredient is present.
     Anyone curious about an ingredient in a cosmetic can find answers in the
International Cosmetic Ingredient Dictionary, published by the Cosmetic,
Toiletries, and Fragrance Association. The dictionary provides a complete list
of the most widely known cosmetic ingredients and their definitions and trade
names. The dictionary, and all other compendia FDA recognizes to name
ingredients, are available for reference at many public libraries, or at the
Office of the Federal Register, 1100 L St., N.W., Washington, DC 20408.
     Cosmetic ingredient declaration regulations apply only to retail
products intended for home use. Products used exclusively by beauticians in
beauty salons or cosmetic studios, and cosmetic samples such as those
distributed free at hotels, are not subject to the ingredient labeling rules.
They must, however, state the name and address of the manufacturer, packer or
distributor, and give an accurate statement of quantity and all necessary
warning statements, as do all other cosmetics that weigh over one-fourth ounce
or one-eighth fluid ounce.

Cosmetics That Are Also Drugs
     Cosmetics making therapeutic claims--that they may affect the structure
or function of the body--are regulated as drugs and cosmetics and must meet
the labeling requirements for both. One way you can tell if you're dealing
with such a product is if the first entry in the ingredient list says "Active
Ingredient." (The active ingredient is the chemical that makes the product
effective, and it must be safe for its intended use.) However, active
ingredients are not legally required to be identified by this term. The law
does require the  active ingredient(s) to be listed first, followed by a list
of all inactive cosmetic ingredients.
     Examples of products that are both cosmetics and drugs are shampoos that
treat dandruff, fluoride toothpastes to prevent dental decay, and sunscreens
and sun-blocking cosmetics, including foundations that contain sunscreens.
(See "Dodging the Rays" in the July-August 1993 FDA Consumer.)
     A product with a drug and cosmetic classification must be scientifically
proven safe and effective for its therapeutic claims before it is marketed. If
the product is not, FDA considers it to be a misbranded drug and can take
regulatory action.

Preventing Problems
     Under FDA's good manufacturing practice guidelines, even cosmetic
products that are not regulated as drugs should be thoroughly tested for
safety and subject to quality control during manufacture. But the law does not
require the agency to review these tests before the cosmetics are marketed.
Nevertheless, FDA does require safety warnings when problems become apparent.
     Misuse of some cosmetic products can cause problems that range in
severity from a mild rash to skin burns, or from burning eyes to blindness.
     Look for warnings about the consequences of misuse required on products
that could be hazardous, in addition to the detailed directions for use that
appear on almost all cosmetics.
     For example, products containing halocarbon or hydrocarbon propellants,
such as aerosol hairsprays or deodorants, must bear the exact wording:
"Warning--Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal."
     All cosmetics in self-pressurized containers, such as shaving creams,
must have specifically worded warnings against spraying near the eyes,
puncturing, incinerating, storing, and intentionally misusing.
     "Keep out of the reach of children" is also required for all products in
pressurized containers. In the case of products intended for use by children,
such as foaming soap, the phrase "except under adult supervision" may be
added.
     Other products requiring specific wording include:
*    Detergent bubble bath products--may irritate skin and the urinary tract 
through excessive use or prolonged exposure. The labeling instructs users to
discontinue the product if rash, redness or itching occur, to consult a
physician if irritation persists, and to keep out of reach of children. These
adverse reactions reportedly occur mostly with prolonged soaks. According to
some studies, the adverse reactions either subside or disappear with
discontinued use. In 1987, FDA started requiring all foaming detergent bath
products not labeled as intended for exclusive adult use to display the
caution statement in addition to directions for use.
*    Feminine deodorant sprays intended for use in the genital area--are for
external use only and should not be applied to broken, irritated or itching
skin. A physician should be consulted if persistent, unusual odor or discharge
occurs. The statement instructs users to discontinue immediately if rash,
irritation or discomfort  develops. Labeling on self-pressurized containers
must state that the product should be sprayed at least 8 inches from the skin.
*    Coal-tar color-containing hair-dye products--contain ingredients that
may cause skin irritation on certain individuals, and a preliminary test
according to the product's accompanying directions should first be made. Users
are cautioned not to dye eyelashes or eyebrows because doing so may cause
blindness. In addition, the ammonia, soaps, detergents, conditioning agents,
and dyes in hair-dye products are all strong eye irritants and could also
cause allergic reactions in other areas. (See "Hair Dye Dilemmas" in the April
1993 FDA Consumer.)
     The following products require explicit warnings, though not with
specific wording:
*    Depilatories and hair straighteners--are highly alkaline; if they are
used incorrectly, they may cause serious skin irritation.
*    Shampoos, rinses and conditioners--can cause eye problems that range
from irritation to permanent damage. If the eye's cornea is scratched or
otherwise damaged, a contaminated product could cause infection. These
cosmetics, as well as others that contain water, usually have antimicrobials
that discourage growth of bacteria.
*    Nail builders (elongators, extenders, hardeners, and enamels)--can cause
irritation, inflammation and infection of the nail bed and nail fold (where
the nail meets the finger) due to residual traces of the methacrylate
monomers. Also, nail hardeners and enamels often contain formaldehyde and
formaldehyde-releasing preservatives, which may cause allergic reactions in
people who are sensitive to them. In addition, the solvents or plasticizers
may be irritating. Nail enamels that are also nail hardeners cause the most
problems. Their high resin content or low concentration of plasticizer seals
the nail surface to air and makes the nail too brittle. Another frequent
problem is flammability during and shortly after application. These products
require a flammability caution.
*    Flammable products such as aerosol hair sprays containing alcohol and an
isobutane propellant--include caution statements on the label. Also, the label
usually cautions about avoiding heat, fire and smoking during use until the
product is fully dry. Last year, FDA received reports of a fatality that
occurred from burns suffered when a woman's hair ignited. Apparently, she
tried to light a cigarette before her hair spray had completely dried.
     Manufacturers often use warning statements on labels when there is even
a small chance of a problem. Baby products often contain such warnings. Baby
powder, for example, if used carelessly and accidentally inhaled by the baby
in large amounts, can block the infant's bronchial and lung passages and cause
suffocation. (For more about cosmetic safety, see "Cosmetic Safety: More
Complex Than at First Blush" in the November 1991 FDA Consumer.)
     Cosmetic labels are more than product advertising. They connect cosmetic
science with consumer protection by providing a means for consumers to know
what's in a product and how to safely use it. A wise consumer will take the
time to read the label to get the best value and results without incurring any
of the possible harmful effects. 

Common Ingredients
     At present, the cosmetic industry selects from more than 5,000 different
ingredients. It's no wonder consumers can be perplexed when they see the list.
Here are some common cosmetic ingredients and their usual functions (active
drug ingredients are not included):

Moisturizers function as a moisture barrier or to attract moisture from the
environment:
*    cetyl alcohol (fatty alcohol)--keeps oil and water from separating, also
a foam booster
*    dimethicone--silicone skin conditioner and anti-foam ingredient
*    isopropyl lanolate, myristate, and palmitate
*    lanolin and lanolin alcohols and oil (used in skin and hair
conditioners)
*    octyl dodecanol--skin conditioner
*    oleic acid (olive oil)
*    panthenol (vitamin B-complex derivative)--hair conditioner
*    stearic acid and stearyl alcohol

Preservatives and antioxidants (including vitamins) to prevent product
deterioration:
*    trisodium and tetrasodium edetate (EDTA)
*    tocopherol (vitamin E)

Antimicrobials to fight bacteria:
*    butyl, propyl, ethyl, and methyl parabens
*    DMDM hydantoin
*    methylisothiazolinone
*    phenoxyethanol (also rose ether fragrance component)
*    quaternium-15

Thickeners and waxes used in stick products such as lipsticks and blushers:
*    candelilla, carnauba, and microcrystalline waxes
*    carbomer and polyethylene--thickeners

Solvents to dilute:
*    butylene glycol and propylene glycol
*    cyclomethicone (volatile silicone)
*    ethanol (alcohol)
*    glycerin

Emulsifiers to break up and refine:
*    glyceryl monostearate (also pearlescent agent)
*    lauramide DEA (also foam booster)
*    polysorbates

Color additives--synthetic organic colors derived from coal and petroleum
sources (not permitted for use around the eye):
*    D&C Red No. 7 Calcium Lake (lakes are dyes that do not dissolve in
water)

Inorganic pigments--approved for general use in cosmetics, including  for the
area of the eye:
*    iron oxides
*    mica (iridescent)

Hair dyes--phenol derivatives used in combination with other chemicals in
permanent (two-step) hair dyes:
*    aminophenols

pH adjusters to stabilize or adjust acids and bases:
*    ammonium hydroxide--in skin peels and hair waving and straightening
*    citric acid--adjusts pH
*    triethanolamine--pH adjuster used mostly in transparent soap

Others:
*    magnesium aluminum silicate--absorbent, anti-caking agent
*    silica (silicon dioxide)--absorbent, anti-caking, abrasive
*    sodium lauryl sulfate--detergent
*    stearic acid--cleansing, emulsifier
*    talc (powdered magnesium silicate)--absorbent, anti-caking
*    zinc stearate--used in powder to improve texture, lubricates.

Judith E. Foulke is a staff writer for FDA Consumer.
 

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