FDA OTC Drug Establishment Registration

If your Canadian, French or Italian company’s products are any of the following, then an OTC Drug Establishment Registration is required, and not MoCRA Registration:

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

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.fda.itbhdg.com/product/otc-cosmetics/