U.S. OTC Requirements: Selected Product Categories

Certain beauty and personal care products may fall under the U.S. OTC drug framework depending on their intended use, active ingredients and product claims. Common categories include sunscreen, acne treatment, anti-dandruff, antiperspirant and selected skin protectants.

Brands developing OTC products should evaluate applicable requirements early in the development process, before formulation, packaging and labeling are finalised.