Cosmetics
COSMETIC
REGISTRATION

Before you export any cosmetic product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

COSMETIC ESTABLISHMENT REGISTRATION

ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:

■ Cosmetic Establishment Registration

■ Cosmetic Product Listing

■ Drug Establishment Registration (OTC Cosmetics)

■ Voluntary Cosmetic Registration Program (VCRP)

■ U.S. Agent Service

■ Label Review

■ Label Design

FDA defines cosmetics by their intended use

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.

LIST OF COSMETIC PRODUCTS

Products included in this definition are:
skin moisturizers, perfumes, lipsticks
fingernail polishes, eye and facial makeup
cleansing shampoos, permanent waves
hair colors and deodorants
any substance intended for use as a component of a cosmetic product.

Soap is not included.

COSMETIC & DRUG PRODUCTS

If the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug.

■ Fluoride toothpaste
■ Antiperspirants
■ Dandruff shampoos
■ sunscreens
■ Soaps and cleansers marketed as “antibacterial”
■ Diaper ointments
are considered “drugs” (OTC – over-the-counter drugs), and therefore require a Drug Establishment Registration.

Your labels must be FDA compliant.

FDA USER FEES

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021). This new fee is additional and required. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.

DUNS NUMBER REQUIREMENT

You must obtain a DUNS Number for your establishment. And, as always, we’ve got you covered.

DUNS Number around the world

DUNS Number in Germany

DUNS Number in Spain & Latin America

DUNS Number in India

DUNS Number in China

DUNS Number in Australia

CONTACT ITB HOLDINGS LLC