USA - FDA Amending Over the Counter Monograph M020: Sunscreen Drug Products for Over the Counter Human Use

This final order amends OTC Monograph M020, as initially set forth in Final Administrative Order OTC000006, to add bemotrizinol as a sunscreen active ingredient.

This final order establishes that for a drug product containing bemotrizinol as a sunscreen active ingredient (at concentrations up to 6 percent, provided the finished drug product provides a minimum sun protection factor (SPF) value of not less than 2) to be legally marketed without an approved application under section 505 of the FD&C Act (21 U.S.C. 355), among other requirements, it must conform to certain conditions that address the concentration of bemotrizinol in the drug product, permitted combinations of bemotrizinol with other sunscreen active ingredients and with skin protectant active ingredients, and permitted dosage forms.