U.S. FDA Approves Bemotrizinol as New OTC Sunscreen Active Ingredient

On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000039, officially amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use to add bemotrizinol as a permitted active ingredient. This marks the first addition of a new active ingredient to the U.S. OTC sunscreen monograph in more than two decades and represents a significant milestone in the modernization of the country's sunscreen regulatory framework. The final order will take effect on August 9, 2026.