On June 10, 2026, FDA issued a final administrative order (OTC000039) amending the OTC monograph for sunscreen drug products to include bemotrizinol as a generally recognized as safe and effective (GRASE) sunscreen ingredient. The amended monograph describes the conditions for use and acceptable dosage forms for bemotrizinol along with required and acceptable labeling statements for bemotrizinol-containing sunscreen products. Going forward, provided that patents or exclusivity do not prevent it, bemotrizinol-containing sunscreens can be marketed in the US without an approved new drug application provided that the products comply with the requirements in the OTC sunscreen monograph and for OTC monograph products, in general.
The addition of bemotrizinol to the sunscreen monograph represents a significant update to the list of GRASE sunscreen ingredients, which up until now consisted of only zinc oxide and titanium dioxide. Other sunscreen ingredients listed in the sunscreen monograph (OTC 000020), while considered to be effective by the FDA when used according to monograph-specified recommendations, lack sufficient safety data to be assessed as GRASE by the FDA. GRASE status for these other 14 sunscreen ingredients listed in the monograph is considered to be pending upon submission of the missing safety data or demonstration that such data requirements can be waived.
So, how did bemotrizinol achieve GRASE status as a new OTC monograph ingredient? The first step was to establish that it meets the requirements for consideration under the OTC monograph amendment process. Products for which this pathway is applicable must either have been marketed in the US prior to 1975 for the same condition in the same dosage form or be able to demonstrate marketing under similar conditions for the same indication in the same dosage form outside the US for a material amount of time (≥5 continuous years) and to a material extent (i.e., 10s of millions of dosage units sold). In the case of bemotrizinol, it was possible to demonstrate that there was sufficient marketing as an over-the-counter drug outside of the US to meet the FDA’s requirements for time and extent of safe use as a sunscreen product.
Having established the time and extent of use was adequate to be considered under the OTC monograph system, an OTC monograph order request (OMOR) to amend the sunscreen monograph was prepared and submitted to the FDA on September 23, 2024 for review for GRASE applicability under the sunscreen monograph. The OMOR contained a combination of original clinical and nonclinical testing data as well as related information and data from independent literature sources that established adequate efficacy and safety of the ingredient when used according to proposed labeling instructions (including concentration, dosage form, and permitted combinations with other sunscreen or skin protectant ingredients).
Of particular concern to the FDA were the ability of bemotrizinol to demonstrate:
Efficacy (i.e., SPF testing according to monograph procedures) in replicate clinical efficacy studies of several drug formulations
Safety in animal assays for carcinogenic, reproductive and developmental, and long-term systemic effects
Safety based on human studies intended to evaluate exposure and potential for adverse effects resulting from application to the skin
Manufacturing concerns were also evaluated including drug substance and drug product impurities, formulation preparation, and potential effects of combination with other sunscreens and skin protective ingredients.
Following internal review by the FDA and consideration of the adequacy of the submitted information, the results of the internal FDA review and a proposed administrative order for amending the OTC sunscreen monograph was published (December 12, 2025) for public review and comment. The results of FDA consideration of public comments and the final administrative order adding bemotrizinol to the sunscreen monograph have now been published.
The entire process leading to the publication of the final administrative order for bemotrizinol were developed in consultation with the FDA through procedures such as formal meetings and written correspondence.