ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240

OTC Cosmetics


Both Cosmetic and Drug products

The ongoing Coronavirus pandemic has created a seismic shift in living and shopping habits worldwide. Cosmetics have borne a significant brunt of this shake-up. Some smart cosmetic companies will be boosting the production of hand soap and hand sanitizers, as demand still outstrips supply.

However, with an increased use of alcohol-based hand sanitizers and foaming hand soaps, we can anticipate consumers wanting to counteract dryness and irritation.

Are considered drug products as well as cosmetics:

■ Sunscreens
■ Anti-acne products
■Topical analgesics
■ Antiperspirants
■ Dandruff products
■ Hair growth / hair loss products
■ Fluoride toothpaste

FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The term “organic” is not defined in either of these laws or the regulations that FDA enforces.

The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) oversees the National Organic Program (NOP). The National Organic Program (NOP) regulations include a definition of “organic”, and provide for certification that agricultural ingredients have been produced under conditions that would meet the definition. They also include labeling standards based on the percentage of organic ingredients in a product.

Cosmetic products labeled with organic claims must comply with both USDA regulations for the organic claim, and FDA regulations for labeling and safety requirements for cosmetics.

Manufacturers, exporters, and importers of OTC cosmetics products must be registered with the FDA as Drug Establishments. ITB HOLDINGS LLC can assist.


The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enacted on March 27, 2020, authorizes the FDA to assess and collect user fees dedicated to OTC monograph drug activities.

Monograph Drug Facility (MDF) Facility Fee


Contract Manufacturing Organization (CMO) Facility Fee


Payment of these annual fees to the U.S. Treasury is now required for initial registration as well as renewal. An account must first be created.