U.S. FDA Proposes Adding New Active Ingredient Bemotrizinol to OTC Sunscreen Monograph

On December 12, 2025, the U.S. Food and Drug Administration (FDA) issued a proposed administrative order to amend the Over-the-Counter (OTC) Monograph M020 for sunscreen drug products. This proposal, initiated by an OTC Monograph Order Request (OMOR) from DSM Nutritional Products LLC, seeks to add bemotrizinol as a new sunscreen active ingredient, determining it to be Generally Recognized as Safe and Effective (GRASE) under specific conditions. Public comments on the proposal will be accepted until January 26, 2026.