What are cosmetics? How are they different
from over-the-counter (OTC) drugs?
Cosmetics are products people use to cleanse or change the
look of the face or body.
Cosmetic products include:
- skin creams
- fingernail polishes
- eye and face make-up products
- permanent waves
- hair dyes
Unlike drugs, which are used to treat or prevent disease in
the body, cosmetics do not change or affect the body's
structure or functions.
What's in cosmetics?
Fragrances and preservatives are the main ingredients in
cosmetics. Fragrances are the most common cause of skin
problems. More than 5,000 different kinds are used in products.
Products marked “fragrance-free” or “without perfume” means
that no fragrances have been added to make the product smell
Preservatives in cosmetics are the second most common cause
of skin problems. They prevent bacteria and fungus from growing
in the product and protect products from damage caused by air
or light. But preservatives can also cause the skin to become
irritated and infected. Some examples of preservatives are:
- imidazolidinyl urea
- DMDM hydantoin
The ingredients below cannot be used, or their use is
limited, in cosmetics. They may cause cancer or other serious
- mercury compounds
- vinyl chloride
- halogenated salicyanilides
- zirconium complexes in aerosol sprays
- methylene chloride
- chlorofluorocarbon propellants
What is the role of the Food and Drug
Administration (FDA) in the cosmetic industry?
A cosmetic maker can sell products without FDA approval. FDA
does not review or approve cosmetics, or their ingredients,
before they are sold to the public. But FDA urges cosmetic
makers to do whatever tests are needed to prove their products
are safe. Cosmetics makers must put a warning statement on the
front labels of products that have not been safety testing,
which reads, "WARNING―The safety of this product has not been
FDA does require safety testing for color additives used in
cosmetics. Cosmetics may only contain approved and certified
colors. You'll find FD&C, D&C, or external D&C
listed on cosmetic labels.
- FD&C – color that can be used only in foods, drugs,
- D&C – color that can be used only in drugs and
- external D&C – color that can be used only in drugs
applied to the surface of the skin and cosmetics
A cosmetic maker also does not have to report product
injuries. FDA collects this information on a voluntary basis
only. Cosmetic makers that want to be a part of this program
send reports to the FDA.
Product recalls are voluntary actions taken by cosmetic makers
too. FDA cannot require cosmetics recalls. But FDA does monitor
cosmetic makers that do a recall. FDA must first prove in court
that a cosmetic product is a danger or somehow breaks the law
before it can be taken off the market.
Are cosmetics safe?
Yes, for the most part. Serious problems from cosmetics are
rare. But sometimes problems can happen.
The most common injury from cosmetics is from scratching the
eye with a mascara wand. Eye infections can result if the
scratches go untreated. These infections can lead to ulcers on
the cornea (clear covering of the eye), loss of lashes, or even
blindness. To play it safe, never try to apply mascara while
riding in a car, bus, train, or plane.
Sharing make-up can also lead to serious problems. Cosmetic
brushes and sponges pick up bacteria from the skin. And if you
moisten brushes with saliva, the problem can be worse. Washing
your hands before using make-up will help prevent this
Sleeping while wearing eye make-up can cause problems too.
If mascara flakes into your eyes while you sleep, you might
wake up with itching, bloodshot eyes, infections, or eye
scratches. So be sure to remove all make-up before going to
Cosmetic products that come in aerosol containers also can
be a hazard. For example, it is dangerous to use aerosol
hairspray near heat, fire, or while smoking. Until hairspray is
fully dry, it can catch on fire and cause serious burns. Fires
related to hairsprays have caused injuries and death. Aerosol
sprays or powders also can cause lung damage if they are deeply
inhaled into the lungs.
To find out more about cosmetic safety, check out the FDA's
Cosmetics True or False Quiz at http://www.cfsan.fda.gov/~dms/costf.html
and find out how much you really know!
How can I protect myself against the
dangers of cosmetics?
- Never drive and put on make-up. Not only does this make
driving a danger, hitting a bump in the road and scratching
your eyeball can cause serious eye injury.
- Never share make-up. Always use a new sponge when
trying products at a store. Insist that salespersons clean
container openings with alcohol before applying to your
- Keep make-up containers closed tight when not in
- Keep make-up out of the sun and heat. Light and heat
can kill the preservatives that help to fight bacteria.
Don't keep cosmetics in a hot car for a long time.
- Don't use cosmetics if you have an eye infection, such
as pinkeye. Throw away any make-up you were using when you
first found the problem.
- Never add liquid to a product unless the label tells
you to do so.
- Throw away any make-up if the color changes, or it
starts to smell.
- Never use aerosol sprays near heat or while smoking,
because they can catch on fire.
- Don't deeply inhale hairsprays or powders. This can
cause lung damage.
- Avoid color additives that are not approved for use in
the eye area, such as "permanent" eyelash tints and kohl
(color additive that contains lead salts and is still used
in eye cosmetics in other countries). Be sure to keep kohl
away from children. It may cause lead poisoning.
What are “cosmeceuticals?”
Some products can be both cosmetics and drugs. This may
happen when a product has two uses. For example, a shampoo is a
cosmetic because it's used to clean the hair. But, an
anti-dandruff treatment is a drug because it's used to treat
dandruff. So an antidandruff shampoo is both a cosmetic and a
drug. Other examples are:
- toothpastes that contain fluoride
- deodorants that are also antiperspirants
- moisturizers and make-up that provide sun
These products must meet the standards for both cosmetics
(color additives) and drugs.
Some cosmetic makers use the term “cosmeceutical” to refer
to products that have drug-like benefits. FDA does not
recognize this term. A product can be a drug, a cosmetic, or a
combination of both. But the term "cosmeceutical" has no
meaning under the law.
While drugs are reviewed and approved by FDA, FDA does not
approve cosmetics. If a product acts like a drug, FDA must
approve it as a drug.
How long do cosmetics last?
You may not be able to use eye make-up, such as mascara,
eyeliner, and eye shadow for as long as other products. This is
because of the risk of eye infection. Some experts recommend
replacing mascara three months after purchase. If mascara
becomes dry, throw it away. Don't add water or, even worse,
saliva to moisten it. That will bring bacteria into the
You may also need to watch certain "all natural" products
that contain substances taken from plants. These products may
be more at risk for bacteria. Since these products contain no
preservatives or have non-traditional ones, your risk of
infection may be greater.
If you don't store these products as directed, they may
expire before the expiration date. For example, cosmetics
stored in high heat may go bad faster than the expiration date.
On the other hand, products stored the way they should be can
be safely used until they expire.
What are hypoallergenic cosmetics?
Hypoallergenic (hy-po-al-ler-gen-ic) cosmetics are products
that makers claim cause fewer allergic reactions than other
products. Women with sensitive skin, and even those with
"normal" skin, may think these products will be gentler. But
there are no federal standards for using the term
hypoallergenic. The term can mean whatever a company wants it
to mean. Cosmetic makers do not have to prove their claims to
Some products that have “natural” ingredients can cause
allergic reactions. If you have an allergy to certain plants or
animals, you could have an allergic reaction to cosmetics with
those things in them. For example, lanolin from sheep wool is
found in many lotions. But it's a common cause of allergies
Can cosmetics cause acne?
Some skin and hair care products can cause acne. To help
prevent and control acne flare-ups, take good care of your
skin. For example, use a mild soap or cleanser to gently wash
your face twice a day. Choose “non-comedogenic” make-up and
hair care products. This means that they don't close up the
Are tattoos and permanent make-up
FDA is looking into the safety of tattoos and permanent
make-up since they are now more popular. The inks, or dyes,
used for tattoos are color additives. Right now, no color
additives have been approved for tattoos, including those used
in permanent make-up.
You should be aware of these risks of tattoos and permanent
- Tattoo needles and supplies can transmit diseases, such
as hepatitis C and HIV. Be sure all needles and supplies
are sterile before they are used on you.
- Tattoos and permanent make-up are not easy to take off.
Removal may cause a permanent change in color.
- Think carefully before getting a tattoo. You could have
an allergic reaction.
- You cannot make blood donations for a year after
getting a tattoo or permanent make-up.
Are cosmetic products with alpha hydroxy
Alpha hydroxy acids (AHAs) come from fruit and milk sugars.
They are found in many creams and lotions. Many people buy
products with AHAs, because they claim to reduce wrinkles,
spots, sun-damaged skin, and other signs of aging. Some studies
suggest they may work.
But are these products safe? FDA has received reports of
reactions in people using AHA products. Their complaints
- severe redness
- swelling (especially in the area of the eyes)
- skin discoloration
AHAs may also increase your skin's risk of sunburn.
To find out if a product contains an AHA, look on the list
of ingredients. By law, all cosmetics have ingredients on their
outer label. AHAs may be called other names, like glycolic acid
and lactic acid.
What precautions should I follow when
using AHA products?
If you want to use AHA products, follow these safety
- Always protect your skin before going out during the
day. Use a sunscreen with a SPF (sun protection factor) of
at least 15. Wear a hat with a brim. Cover up with
lightweight, loose-fitting, long-sleeved shirts, and
- Buy products with good label information:
- a list of ingredients to see which AHA
or other chemical acids are in the product
- the name and address of the maker
- a statement about the product's AHA and
The first two have to be on the label. The third is one is
by choice. You can call or write the maker to find about a
product's AHA and pH levels.
- Buy only products with an AHA level of 10 percent or
less and a pH of 3.5 or more.
- Test a small area of skin to see if it is sensitive to
any AHA product before using a lot of it.
- Stop using the product right away if you have a
reaction, such as stinging, redness, or bleeding.
- Talk with your doctor or dermatologist (a doctor that
treats skin problems) if you have a problem. You also can
report your reaction to the FDA. Write to: Office of
Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway,
College Park, MD 20740-3835. Or you can call them at (202)
Are hair dyes safe?
The decision to change your hair color may be a hard one.
Some studies have linked hair dyes with a higher risk of
certain cancers, while other studies have not found this link.
Most hair dyes also don't have to go through safety testing
that other cosmetic color additives do before hitting store
shelves. Women are often on their own trying to figure out
whether hair dyes are safe.
When hair dyes first came out, the main ingredient in
coal-tar hair dye caused allergic reactions in some people.
Most hair dyes are now made from petroleum sources. But FDA
still considers them to be coal-tar dyes. This is because they
have some of the same compounds found in these older dyes.
Cosmetic makers have stopped using things known to cause
cancer in animals. For example, 4-methoxy-m-phenylenediamine
(4MMPD) or 4-methoxy-m-phenylenediamine sulfate (4MMPD sulfate)
are no longer used. But chemicals made almost the same way have
replaced some of the cancer-causing compounds. Some experts
feel that these newer ingredients aren't very different from
the things they're replacing.
Experts suggest that you may reduce your risk of cancer by
using less hair dye over time. You may also reduce you risk by
not dyeing your hair until it starts to gray.
What precautions should I take when I dye
You should follow these safety tips when dyeing your
- Don't leave the dye on your head any longer than
- Rinse your scalp thoroughly with water after use.
- Wear gloves when applying hair dye.
- Carefully follow the directions in the hair dye
- Never mix different hair dye products.
- Be sure to do a patch test for allergic reactions
before applying the dye to your hair. Almost all hair dye
products include instructions for doing a patch test. It's
important to do this each time you dye your hair. Your
hairdresser should also do the patch test before dyeing
your hair. To test, put a dab of hair dye behind your ear,
and don't wash it off for two days. If you don't have any
signs of allergic reaction, such as itching, burning, or
redness at the test spot, you can be somewhat sure that you
won't have a reaction to the dye applied to your hair. If
you do react to the patch test, do the same test with
different brands or colors until you find one to which
you're not allergic.
- Never dye your eyebrows or eyelashes. An allergic
reaction to dye could cause swelling or increase risk of
infection in the eye area. This can harm the eye and even
cause blindness. Spilling dye into the eye by accident
could also cause permanent damage. FDA bans the use of hair
dyes for eyelash and eyebrow tinting or dyeing even in
Are lead acetates safe in hair dyes?
Lead acetate is used as a color additive in "progressive"
hair dye products. These products are put on over a period of
time to produce a gradual coloring effect. You can safely use
these products if you follow the directions carefully. This
warning statement must appear on the product labels of lead
acetate hair dyes:
"Caution: Contains lead acetate. For external use only. Keep
this product out of children's reach. Do not use on cut or
abraded scalp. If skin irritation develops, discontinue use. Do
not use to color mustaches, eyelashes, eyebrows, or hair on
parts of the body other than the scalp. Do not get in eyes.
Follow instructions carefully and wash hands thoroughly after
Is it safe to dye my hair when I'm
We don't know much about the safety of hair dyes during
pregnancy. It's likely that when you apply hair dye, only a
small amount is absorbed into your system. So very little
chemicals, if any, would be able to get to your baby. In the
few animal and human studies that have been done, no changes
were seen in the developing baby. Talk with your doctor if you
have questions or concerns.
For More Information
For more information on cosmetics or hair dye, contact the
National Women's Health Information Center at 800-994-9662 or
the following organizations:
Food and Drug Administration (FDA), OPHS,
Phone: (888) 463-6332 (Consumer Information)
Internet Address: http://www.fda.gov
Office of Cosmetics and Colors Automated Information
Line, FDA, OPHS, HHS
Phone: (888) 723-3366
Internet Address: http://vm.cfsan.fda.gov/~dms/cos-toc.html
American Academy of Dermatology (AAD)
Phone: (888) 462-3376
Internet Address: http://www.aad.org
Mayo Foundation for Medical Education and Research
Phone: (480) 301-8000
Internet Address: http://www.mayoclinic.com