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