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Cosmetics DEFINED

FDA does not have the legal authority to approve cosmetics before they go on the market.

Color additives used in cosmetics (except coal tar hair dyes), are approved by the FDA.

Are defined as cosmetics:

  • skin moisturizers
  • perfumes
  • lipsticks
  • fingernail polishes
  • eye and facial makeup
  • cleansing shampoos
  • permanent waves
  • hair colors
  • deodorants
  • sunscreens
  • any substance intended for use as a component of a cosmetic product

Soap is not included.

Under the law, cosmetics must not be “adulterated” or “misbranded”. They must be safe for consumers when used according to directions on the label, and they must be properly labeled.

Whether a product is a cosmetic or a drug is determined by a product’s intended use.

Both cosmetics and drugs

The following products require a drug establishment registration:

  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Deodorant that is also antiperspirant
  • Moisturizer and makeup marketed with sun-protection claims
  • Sunscreens
Cosmetic Establishment Registration

Here are the options for your company:

Drug Establishment Registration

    OTC Cosmetics

Voluntary Cosmetic Registration Program (VCRP)

    Conventional Cosmetics

Your product’s ingredients and or intended use will determine which registration is required.

Please provide

  • Company DUNS Number
  • FDA Compliant Label
  • U.S. Toll Free Number

U.S. Toll Free Number is preferred on OTC Cosmetics to report health related issues.

Need Label Review? ITB HOLDINGS LLC provides assistance.

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