In today’s prepublication of the Federal Register, the FDA, in response to an over-the-counter (OTC) monograph order request (OMOR), announced the availability of an amended final administrative order (OTC000039) for sunscreen ingredients permitting the over-the counter (OTC) use of the ingredient bemotrizinol, considering it to be generally recognized as safe and effective (GRASE) for its intended use.  “Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.”

Bemotrizinol provides protection against both ultraviolet A and B rays, and has low levels of absorption through the skin into the body.  It has been found to be GRASE for “use in sunscreens by adults and children 6 months of age and older.”  According to HHS Secretary Robert F. Kennedy, Jr. (here), “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

The monograph amendment permits the use of bemotrizinol in concentrations up to 6 percent as a sunscreen active ingredient.  The request for a monograph revision was made by DSM Nutritional Products LLC on September 23, 2024 by submitting “a Tier 1 OMOR requesting FDA issue an administrative order finding that a sunscreen drug product containing bemotrizinol as an active ingredient is GRASE under the conditions described in OTC Monograph M020.”  The monograph will permit product to be marketed “in the following dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick, and spray, provided that the sunscreen drug product in spray dosage form is manufactured and packaged with no propellant or is manufactured and packaged in a spray delivery system where all propellant is isolated from the drug product formulation within the container closure system, and there is no contact between the propellant and the drug product formulation.”

The newly included sunscreen ingredient can also be included with other monograph ingredients, as stated in the final order.