FDA Proposes Expansion of US Sunscreen Ingredient Standards with Bemotrizinol

Today, the US Food and Drug Administration (FDA) announced a significant step toward expanding the range of ultraviolet (UV) filters available in the US by proposing the addition of bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products.¹ This action is part of a broader initiative within the Office of Nonprescription Drugs to advance sunscreen innovation and modernize the OTC drug regulatory framework.

Bemotrizinol (also known internationally as BEMT or Tinosorb S) is an oil-soluble, organic, broad-spectrum UV filter that has been used for years in many global markets but has not previously been included in US sunscreen formulations. According to the FDA’s review, bemotrizinol demonstrates robust UVA and UVB protection, exhibits minimal systemic absorption, and is associated with low rates of skin irritation. If the proposed order is finalized, bemotrizinol will be recognized as generally recognized as safe and effective (GRASE) for individuals 6 months of age and older (alongside zinc oxide and titanium dioxide), thereby expanding the sunscreen options available to US consumers and patients.

“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA Commissioner Marty Makary, MD, MPH, said in a statement. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”¹

Under the OTC monograph system, sunscreen products may enter the market without individual product approvals if they comply with established monograph requirements, including permitted active ingredients, uses, and concentrations. Regulatory changes to monographs occur through administrative orders, a process streamlined by reforms enacted in the CARES Act, which has facilitated more efficient updates of OTC drug standards.

The proposal to add bemotrizinol follows an OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC, seeking authorization for bemotrizinol at concentrations up to 6%. While the ingredient has a long history of international use, the FDA has not previously approved any US drug product containing bemotrizinol nor incorporated it into the sunscreen monograph. The proposed BEMT filter has already been approved in Europe since 2000. The FDA has approved 16 UV filters over the years, with the last one being in 1999.

“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” said Karen Murry, MD, Acting Director of the Office of Nonprescription Drugs. “The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process, and we look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past.”¹

In a statement from the American Academy of Dermatology (AAD), president Susan C. Taylor, MD, FAAD, “applauded the FDA for taking the first steps in more than 2 decades to provide more safe and effective sunscreen options to the American public.”²

“The Academy has been advocating for many years for the availability of more sunscreen options for US consumers. The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients,” she added.

The AAD has consistently urged the FDA to include innovative sunscreen filters that expand UV protection for all patients. For example, the AAD successfully advocated for the FDA’s OTC user fee program to include increased access to OTC products, including the approval of new and innovative sunscreens. This legislation streamlined the FDA’s review process for assessing the safety and effectiveness of new ingredients.

"I am excited by the news the FDA is proposing to add bemotrizinol to the approved list of sunscreen ingredients. There is a high unmet need for chemical sunscreens that are both broad-spectrum, absorbing UVA and UVB rays, while also being safe and minimizing or eliminating bloodstream absorption. The hope is bemotrizinol can fulfill this need in the chemical sunscreen space and complement mineral-based sunscreens in terms of efficacy and safety," Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, and Dermatology Times Editor in Chief, said in an exclusive statement.

The agency is currently soliciting public comments on the proposed order and the AAD plans to review and submit its feedback. If, after reviewing comments and finalizing its assessment, the FDA concludes that bemotrizinol meets GRASE criteria, it will be formally added to OTC Monograph M020 as an approved sunscreen active ingredient.

References

1. FDA Proposes Expanding Sunscreen Active Ingredient List. News release. US Food and Drug Administration. Published December 11, 2025. Accessed December 11, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list?utm_medium=email&utm_source=govdelivery

2. American Academy of Dermatology Association Statement on FDA Proposal for New Sunscreen Ingredient. News release. American Academy of Dermatology Association. Published December 11, 2025. Accessed December 11, 2025. https://www.aad.org/news/statement-fda-proposal-new-sunscreen-ingredient