US FDA Approves Bemotrizinol as New OTC Sunscreen Active Ingredient
The U.S. FDA has added bemotrizinol to the OTC sunscreen monograph, making it the first new active ingredient approved through this pathway in nearly two decades.
US FDA Approves Bemotrizinol as New OTC Sunscreen Active Ingredient
US FDA Approves Bemotrizinol as New OTC Sunscreen Active Ingredient
On 10 June 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000039, adding bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products. The order officially recognises bemotrizinol as generally recognised as safe and effective (GRASE) for specified uses and lists it under Monograph M020 for Sunscreen Drug Products for Over-the-Counter Human Use.
This approval marks the first new sunscreen active ingredient to be added to the OTC monograph in approximately two decades. The decision enables U.S. manufacturers to formulate with a modern UV filter that is already widely used in other markets, such as the European Union, which may allow for broader UV spectrum coverage and more globally aligned product portfolios.
The use of the administrative order mechanism sets a clear regulatory precedent for how additional sunscreen actives might be approved in the future. For global brands, this development helps to reduce regulatory fragmentation and facilitates closer harmonisation between U.S. and international sunscreen formulations.
You may access the final administrative order here.
Originally published at worldover.io