All cosmetics, whether they are sold on a retail basis to consumers or marketed exclusively
for salon or workplace use, are subject to the FD&C Act. This law and regulations enacted under its
authority require the cosmetic label to state the name and place of business of the manufacturer, packer
or distributor; an accurate statement of the quantity of contents; and any appropriate directions for
safe use and/or warning statements. This information must comply with additional regulatory requirements.
It must be prominent and appear in the proper location on the label.
Regulations enacted under the FPLA require ingredients to be listed on the labels of
cosmetics sold on a retail basis to consumers -- even if the label states "For professional use
only." Consumers can use the ingredient declaration to identify ingredients they wish to avoid.
Ingredients are listed in descending order of predominance, that is, with the ingredient present in the
greatest amount listed at the beginning and those present in the smallest amounts listed at the end.
Special rules apply to the ingredient declaration on products that are both
cosmetics and over-the-counter drugs. An example of such a product is an anti-dandruff shampoo: A
shampoo is a cosmetic, while an anti-dandruff treatment is a drug. Regulations enacted in 1999 require
such combination products to have the drug ingredients listed separately as "Active Ingredients,"
in alphabetical order, followed by the cosmetic ingredients, which are listed as "Inactive Ingredients"
in descending order of predominance.
In addition to the immediate label, FDA regulates all cosmetic product "labeling."
The definition of labeling includes all written, printed, or graphic matter that appears on the product,
its containers, or its wrappers, as well as any such matter that accompanies the product. Typically,
materials such as promotional literature, product catalogs, and flyers fit this definition of labeling.
FDA also has considered promotional statements appearing on Internet sites to constitute labeling, especially
on those sites where the promoted product can be purchased. However, unfair or deceptive advertising
that appears in magazines, in newspapers, or on television generally falls under the authority of the
Federal Trade Commission.
Cosmetic firms should refer to FDA's Cosmetic Labeling Manual and the regulations
related to cosmetics for more detailed labeling information.
The following FDA Consumer magazine article, published in 1994, provides additional information
on understanding the cosmetic label. Linda M. Katz, M.D., M.P.H. has been director of FDA's Office of
Cosmetics and Colors since September 2002.
U. S. Food and Drug Administration
FDA Consumer
May 1994
DECODING THE COSMETIC LABEL
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 hit 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 Chemical Translations.) 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 vary
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 sunblocking 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
imitation 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 requiting 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 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.
Where's the Label Information?
The placement of required information on the
cosmetic label may vary with the packaging and container.
Written by Judith E. Faulke
FDA CONSUMER, May 1994
