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COSMETICS
COSMETICS

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.

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.

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:

OTC (Over-the-Counter) Cosmetics

Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Also, the use of specific active ingredients may result in a product being regulated as a drug.

No OTC Cosmetic Establishment Registration is possible without the payment of $20,322.00 User Fee to the U.S. Treasury, first.

Manufacturers, Exporters and Importers are expected to know whether their products are conventional cosmetics or OTC cosmetics.

Learn More

Voluntary Cosmetic Registration Program (VCRP)

Conventional Cosmetics

Your product does not meet the definition of an OTC cosmetic, as indicated.

In this case, your company’s registration is not required, and the listing of related products, as well. However, VCRP is requested by most wholesale distributors and Amazon.com, Inc.

Registration of a cosmetic establishment, assignment of an establishment registration number, filing a cosmetic product, or assignment of a Filing Cosmetic Product Ingredient Statements (CPIS) number, does not mean that FDA has approved the firm or its products.

A cosmetic manufacturer, packer, or distributor can file a statement for each product entering into commercial distribution in the United States.

Conventional cosmetic establishment registration is exempt from the annual User Fee. Only a Service Fee is required. See here.

OTC COSMETIC OR CONVENTIONAL COSMETIC?

Need help determining whether your product is a  conventional or over-the-counter cosmetic before manufacturing, exporting or importing?

OTC COSMETICS
ESTABLISHMENT REGISTRATION
  • Company Registration
  • Product Listing
  • U.S. Agent Service
LIMITED OFFER
$350.00 | ANNUAL SERVICE FEE

$20,322.00 ANNUAL USER FEE

Remember, 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? Simply contact ITB HOLDINGS LLC.