Cosmetics Safety

Food and Drug Administration

https://www.fda.gov/cosmetics

The United States Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance." Included in this definition are products such as: skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

People use cosmetics to keep clean and enhance their beauty. These products range from lipstick and nail polish to deodorant, perfume, hairspray, shampoo, shower gel, tattoos, hair adhesives, hair removal products, hair dyes, most soaps, some tooth whiteners, and some cleansing wipes. It is important to use cosmetics products safely. EYB Cosmetics reminds you to get the facts before using our cosmetics products:

  • General Tips
  • Eye Make-Up Tips
  • Understanding Cosmetic Labels
  • Report Problems to United States Food and Drug Administration (FDA)

EYB Cosmetics offers more than 500 shades of professional quality cosmetics for All Ages, All Races, and All Genders.

*NOTE: Colors in the images online may not match the actual color of the product(s) you receive; this is because of the different devices used to display colors. Therefore, a color may appear slightly different based on your skin tone (warm, cool, etc.) or complexity.

**NOTE: All cosmetics (blushes, lipsticks, shadows, glosses, foundations, etc.) perform based on the climate (hot, cold, dry, most, etc.) they are used in. The amount of moisture (oil, dry, wet, etc.) in a person’s skin also affects the cosmetic’s performance.

1. General Tips

Follow these safety guidelines when using cosmetics products of any type:

  • Read the label. Follow all directions and pay attention to all warnings.
  • Wash your hands before you use the product.
  • Do not share makeup.
  • Keep the containers clean and tightly closed when not in use, and protect them from extreme temperatures.
  • Throw away cosmetics if there are changes in color or smell.
  • Use aerosols or sprays cans in well-ventilated areas. Do not use them while you are smoking or near an open flame. It could start a fire.

2. Eye Make-Up Tips

There are special safety guidelines for using cosmetics in the eye area. Be sure to keep these practices in mind:

  • Do not use cosmetics near your eyes unless they are meant for your eyes. For example, do not use lip liner on your eyes!
  • Do not add saliva or water to mascara. You could add germs.
  • Throw away your eye makeup if you get an eye infection. The makeup could have contamination.
  • Do not dye or tint your eyelashes or eyebrows. The United States Food and Drug Administration (FDA) has not approved any products for permanent dyeing or tinting of your eyelashes or eyebrows.

3. Understanding Cosmetic Labels

Being familiar with the product you are using is important. Be sure to read the entire label, including the list of ingredients, warnings, and tips on how to use the product safely. Also, be aware of the following terms that you may see on the label:

  • Hypoallergenic: Do not assume that the product will not cause allergic reactions. The United States Food and Drug Administration (FDA) does not define “hypoallergenic.”
  • Organic or Natural: The source of the ingredients does not determine how safe it is. Do not assume that these products are safer than products made with ingredients from other sources. The U.S. Department of Agriculture (USDA) defines what it means for cosmetics labeled “organic.” However, there is no formal USDA or FDA definition for “natural.”
  • Expiration Dates: The law does not require cosmetics to have an expiration date. However, a cosmetic product may go bad if you store it the wrong way; for example, in a place that is too warm or too moist. Marking the container with the date you open a cosmetic will help you keep track of the age of your cosmetics.

4. Report Problems to Food and Drug Administration

Current laws do not require cosmetics approval by United States Food and Drug Administration (FDA) before selling these products. However, the FDA does monitor consumer reports of adverse health-related problems with cosmetic products.

If you are experiencing health-related problems with your cosmetics, please notify the United States Food and Drug Administration if you experience a rash, redness, burn, or another unexpected reaction after using a cosmetic product. Also, please contact the FDA if you notice a problem with the cosmetic product itself, such as a bad smell, color change, or foreign material in the product.

Follow these steps:

  1. Stop using the product.
  2. Call your healthcare provider to find out how to take care of the problem.
  3. Report problems to the United States Food and Drug Administration in either of these ways:
  • Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program:

Phone: 1-800-FDA-1088

Online: File a voluntary report

  • Contact the Consumer Complaint Coordinator in your area.

FREQUENTLY ASKED QUESTIONS

1. Why are cosmetics not FDA-approved? If cosmetics are not FDA-approved, are regulations applied?

FDA-regulated does not mean FDA-approved. The FDA does not have the legal authority to approve cosmetics before they go on the market, although it does approve color additives used in them (except coal tar hair dyes).

However, under the law, cosmetics must not be "contaminated" or "misbranded." For example, they must be safe for consumers to use according to directions on the label, or in the customary or expected way, and properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

The FDA can take action against a cosmetic on the market if it has reliable information showing that a product is contaminated or misbranded. The FDA will take action within its legal authority, based on public health priorities and available resources.

2. Are personal care products, regulated as cosmetics?

People often use the term "personal care products" to refer to a wide variety of items that we commonly find in the health and beauty departments of drug and department stores. These products may fall into a number of different categories under the law.

  • Products intended to cleanse or beautify are, regulated as cosmetics. Some examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants. These products and their ingredients are not subject to FDA premarket approval, except color additives (other than coal tar hair dyes). Cosmetic companies have a legal responsibility for the safety of their products and ingredients.
  • Products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. This is true even if a product affects how you look. Some examples are treatments for dandruff or acne, sunscreen products, antiperspirants, and diaper ointments. Generally, drugs must receive premarket approval by FDA or, if they are nonprescription drugs, conform to special regulations, called "monographs," for their category.  
  • Some are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as moisturizers and makeup with sun protection factor (SPF) numbers. They must meet the requirements for both cosmetics and drugs.
  • Some may belong to other categories, including medical devices (such as certain hair removal and microdermabrasion devices), dietary supplements (such as vitamin or mineral tablets or capsules), or other consumer products (such as manicure sets).

    The law does not recognize any such category as "cosmeceuticals." If a product has drug properties, it must meet the requirements for drugs. 

    3. Does the Food and Drug Administration require animal testing for cosmetics?

    The Federal Food, Drug, and Cosmetic Act does not specifically require the use of animals in testing cosmetics for safety, nor does it subject cosmetics to FDA premarket approval. However, the FDA has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing.

    Animal testing, by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.

    The FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when testing animals for the safety of cosmetic products. EYB Cosmetics will continue to be a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.

    4. Does the Food and Drug Administration prohibit ingredients from use in cosmetics?

    With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from the FDA. The Federal Food, Drug, and Cosmetic Act requires that color additives used in cosmetics must be tested for safety and be listed by the FDA for their intended uses.

    Regulations restrict or prohibit the use of the following ingredients in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, and zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.

    5. Does the Food and Drug Administration approve the color additives used in cosmetics? If so, how does the Food and Drug Administration determine their safety?

    The Food and Drug Administration regulates color additives used in the United States, including those used in food, dietary supplements, drugs, cosmetics, and medical devices. The agency evaluates scientific data and information to ensure that a color additive is safe for its intended purposes. Any food, cosmetic, or drug, as well as many medical devices that contain an unapproved color additive would be considered adulterated under U.S. law and would be subject to enforcement action to remove it from commerce.  

    6. What should I do if I have a reaction (side effect) to a cosmetic product?

    Products intended to cleanse or beautify a person’s body generally regulate as cosmetics. Some examples are skin moisturizers, hair colors, perfumes, makeup, and even tattoos.

    If you have a reaction (side effect) to a cosmetic product, you should:

    • Tell your doctor or other health care provider,
    • Report it to the cosmetic manufacturer, and
    • Submit a complaint by reporting the problem to the FDA

      You can also contact the FDA district office, consumer complaint coordinator, for your geographic area or call FDA at 1-800-332-1088.

      7. What is the shelf life of cosmetics?

      The shelf life for eye-area cosmetics is more limited than for other products. Because of repeated microbial exposure during use by the consumer and the risk of eye infections, some industry experts recommend replacing mascara three (3) months after purchase. If mascara becomes dry, discard it. Do not add water or, even worse, saliva to moisten it, because that will introduce bacteria into the product. If you have an eye infection, consult a physician immediately, stop using all eye-area cosmetics, and discard those you were using when the infection occurred.

      Among other cosmetics that are likely to have an unusually short shelf life are certain "all natural" products that may contain plant-derived substances conducive to microbial growth. It also is important for consumers and manufacturers to consider the increased risk of contamination in products that contain non-traditional preservatives or no preservatives at all.

      Consumers should be aware that expiration dates are simply "rules of thumb," and that a product's safety may expire long before the expiration date if the product has not been properly stored. Cosmetics that have been improperly stored: for example, exposed to high temperatures or sunlight, or opened and examined by consumers prior to final sale, may deteriorate substantially before the expiration date. On the other hand, products stored under ideal conditions may be acceptable long after the expiration dated.

      Sharing makeup increases the risk of contamination. "Testers" commonly found at department store cosmetic counters are even more open to contamination than the same products in an individual's home. If you feel you must test a cosmetic before purchasing it, apply it with a new, unused applicator, such as a fresh cotton swab.

      8. What are "hypoallergenic" cosmetics?

      Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may believe that these products will be gentler to their skin than non-hypoallergenic cosmetics.

      There are no Federal standards or definitions governing the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to the FDA.

      The term "hypoallergenic" may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.

      9. Are tattoos and permanent makeup safe? How about henna and other temporary tattoos?

      The FDA is looking into the safety of tattoos and permanent makeup because of their growing popularity. For example, we the FDA is looking at tattoo removal, adverse reactions to tattoo colors, and infections that result from the use of these products.

      Consumers should think carefully before getting a tattoo or permanent makeup and consider these facts:

      • Some people have had bad reactions to tattoo and permanent makeup inks; some have suffered permanent disfigurement.
      • Tattoos and permanent makeup cases may cause permanent discoloration.
      • Color additives for tattoos, including those used in permanent makeup, do not require Food and Drug Administration approval.
      • Unsterile tattooing equipment and needles can transmit infectious disease, such as hepatitis; it is extremely important to confirm that all equipment is clean and sanitary before use.
      • Contaminated inks have caused infections, even when the tattoo artist followed hygienic procedures.
      • If you get a tattoo at a facility not regulated by your state or at facilities that use unsterile equipment, or re-use ink, you cannot donate blood or plasma for twelve months.

        Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Many contain color additives approved for cosmetic use on the skin. However, the FDA has received reports of allergic reactions to some temporary tattoos.

        Henna, a coloring made from a plant, is as a hair dye, and not approved for direct application to the skin. In addition, products marketed as "Henna" may contain other ingredients. The FDA has received reports of injuries to the skin both from products marketed as Henna and from those marketed as "Black Henna."

        10. Do cosmetics contain harmful contaminants, such as lead? What does FDA do to guard against them?

        Under the Federal Food, Drug, and Cosmetic Act, cosmetics must be safe for consumers when used as intended. If a cosmetic is harmful to consumers, the law considers it adulterated, and it is against the law to market adulterated cosmetics in interstate commerce. It does not matter whether the ingredients or contaminants cause the safety problem. Companies and individuals who market cosmetics have a legal responsibility for the safety of their products.

        The FDA monitors cosmetics on the market to watch for potential safety problems, including potential contaminants. The FDA also stay abreast of scientific research, so that we can be aware of potential problems. The FDA takes action against products that do not comply with the law and against companies and individuals who market them.

        The Food and Drug Administration takes the following steps to discover cosmetics that may contain harmful contaminants:

        • Inspecting Imports. One way that the FDA guards against contaminated cosmetics is by working with U.S. Customs and Border Protection staff to inspect imported products. Because the FDA cannot inspect every shipment, the FDA issues Import Alerts to help inspection staff look out for products that are most likely to pose a safety hazard. A number of the Import Alerts for cosmetics warn about products that may contain harmful contaminants. The FDA does not allow unsafe cosmetics entry into the United States.
        • Inspecting Manufacturers. The FDA has issued guidance to manufacturers on how to keep two kinds of contaminants, nitrosamines and dioxane, from forming during the manufacturing process. The FDA inspectors check to make sure manufacturers are following the proper procedures.
        • Color Additives. Except for those intended as coal tar hair dyes, color additives used in cosmetics require FDA approval and listed in a regulation that states its permitted use, as well as all specifications and restrictions. These regulations set strict limits on contaminants. The FDA sets these limits based on how much of the color additive is acceptable and the routes of exposure under the intended conditions of use.

        11. Are there safety concerns related to the use of parabens in cosmetics?

        Parabens are preservatives that prevent the growth of potentially harmful bacteria that could live in some cosmetics products. Safety questions about the use of parabens in cosmetics focus on the parabens' potential to act like estrogen, a hormone that can be associated with the development of breast cancer. Studies have shown, however, that parabens have significantly less estrogenic activity than the body's naturally occurring estrogen. Parabens have not shown to be harmful as used in cosmetics, where they are present only in very small amounts.

        12. What precautions should you take if you dye your hair?

        People who dye their hair should follow these safety precautions:

        • Follow the directions in the package. Pay attention to all "Caution" and "Warning" statements.
        • Do a patch test before using dye on your hair. A good rule of thumb is to “Rub a tiny bit of the dye on the inside of your elbow or behind your ear. Leave it there for two days. If you get a rash, do not use the dye on your hair.” You should do the test each time you dye your hair. (NOTE: Salons should also do the patch test before dyeing your hair.)
        • Never dye your eyebrows or eyelashes; this can hurt your eyes. You might even go blind. The FDA does not allow using hair dyes on eyelashes and eyebrows.
        • Keep hair dyes out of the reach of children.
        • Do not leave the dye on longer than the directions say you should.
        • Rinse your scalp well with water after dyeing.
        • Wear gloves when you apply the hair dye.
        • Never mix different hair dye products. This can hurt your hair and scalp. 

          13. What precautions should you take when using eye cosmetics?

           If you use eye cosmetics, the FDA urges you to follow these safety tips:

          • If any eye cosmetic causes irritation, stop using it immediately. If irritation persists, see a doctor.
          • Avoid using eye cosmetics if you have an eye infection or the skin around the eye is inflamed. Wait until the area heals. Discard any eye cosmetics you were using when you got the infection.
          • Be aware that there are bacteria on your hands that, if placed in the eye, could cause infections. Wash your hands before applying eye cosmetics.
          • Make sure that any instrument you place in the eye area is clean.
          • Do not share your cosmetics. Another person's bacteria may be hazardous to you.
          • Do not allow dust, dirt or soil to contaminate cosmetics. Keep containers clean.
          • Do not use old containers of eye cosmetics. Discard mascara three months after purchase.
          • Discard dried-up mascara. Do not add saliva or water to moisten it. The bacteria from your mouth may grow in the mascara and cause infection. Adding water may introduce bacteria and will dilute the preservative that protect cosmetics against microbial growth.
          • Do not store cosmetics at temperatures above 85 degrees F. Cosmetics held for long periods in hot cars, for example, are more susceptible to deterioration of the preservative.
          • When applying or removing eye cosmetics, be careful not to scratch the eyeball or other sensitive area. Never apply or remove eye cosmetics in a moving vehicle.
          • Do not use any cosmetics near your eyes not intended specifically for that use. For instance, do not use a lip liner as an eyeliner. You may be exposing your eyes to contamination from your mouth or color additives not approved for use in the area of the eye.
          • Avoid color additives not approved for use in the area of the eye, such as "permanent" eyelash tints and kohl. Be especially careful to keep kohl away from children, since reports have linked it to lead poisoning.

            14. Where can I learn more about cosmetic safety and how cosmetics regulations?

            Please visit the FDA's main Cosmetics page, where you will find links to information on cosmetic labeling and label claims, product and ingredient safety, regulatory information, and more.

            The following are some of the "topics" under Cosmetics that you may find useful:

            • Guidance & Regulation, for links to the laws and regulations that apply to cosmetics, and related resources
            • Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), to learn how different "personal care products" are regulated
            • Labeling & Label Claims, for information on what must appear on cosmetic label
            • Products & Ingredients, where you will find links to information on cosmetic products and ingredients that people often ask about
            • Resources for Consumers, for links to information consumers often request