While bemotrizinol(187393-00-6) is marketed in many countries as a sunscreen active ingredient, the FDA has not previously approved an application for a drug product containing bemotrizinol and added it to the sunscreen monograph. However, it recently agreed to review DSM Nutritional Products LLC’s application to add bemotrizinol, at a concentration of up to 6%, as a new active ingredient to the OTC sunscreen monograph.
Based on data reviewed by the FDA, bemotrizinol provides protection against ultraviolet A and B rays, has low absorption through the skin, and rarely causes skin irritation. If this action finalized, bemotrizinol would be an additional sunscreen active ingredient that the FDA considers generally safe and effective for use by adults and children 6 months of age and older, expanding consumer choice.
If FDA concludes that bemotrizinol is generally recognized as safe and effective(GREASE) as a sunscreen ingredient, the agency will issue a final order to add the ingredient to OTC Monograph M020.
