FDA Proposes First New Sunscreen Ingredient in Decades

The U.S. Food and Drug Administration (FDA) on Dec. 11, 2025, announced a proposed administrative order to add bemotrizinol as a new active ingredient to the over-the-counter (OTC) sunscreen monograph. This is the first new sunscreen ingredient to be proposed to be legally marketed in the U.S. for decades and marks a significant step in the agency's stated efforts to modernize the regulation of OTC sunscreen products. Bemotrizinol has been widely used in Europe, Australia and Asia for decades and was approved by Health Canada in 2023. FDA Commissioner Marty Makary noted, "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."

Background on Sunscreen Regulation

The regulation of OTC sunscreens in the U.S. has been marked by significant delays, with no new active ingredients approved since the 1990s. This stagnation denied Americans access to a broader array of safe sunscreens and left the U.S. market lagging generations behind the sunscreen filters available in other parts of the world. In 2014, the U.S. Congress enacted the Sunscreen Innovation Act (SIA) to expedite the review of backlogged sunscreen ingredient applications, replacing the lengthy notice-and-comment rulemaking process with a more efficient administrative order process, which can be initiated by the FDA or a sunscreen sponsor. However, the SIA's implementation did not result in any new approvals, as the FDA required animal testing and introduced novel and burdensome testing standards, such as the Maximum Usage Trial (MUsT), which were not harmonized with international regulatory protocols and stifled the approval process.

Recognizing the systemic issues with the monograph process, Congress enacted comprehensive reforms – based on the SIA – as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act fundamentally restructured the OTC monograph framework with a user fee-based system that extended the administrative order process from just sunscreens to all OTC ingredients. The creation of a user fee provides the FDA with dedicated resources, funded by industry user fees, to review and approve new OTC products in a more timely manner. Finally, the reforms allow for more collaborative engagement, permitting companies to meet with the FDA as their ingredient applications are under consideration.

FDA Treatment of Bemotrizinol

On Dec. 11, 2025, the FDA issued a proposed administrative order (OTC000039) to amend OTC Monograph M020 to add bemotrizinol as a generally recognized safe and effective (GRASE) active ingredient for use in sunscreens at concentrations up to 6 percent. The action was initiated via an OTC Monograph Order Request (OMOR) submitted by a company specializing in health, nutrition and beauty products on Sept. 23, 2024. According to the FDA, its review of the data for bemotrizinol indicates that the ingredient provides broad-spectrum UVA and UVB protection, exhibits low systemic absorption through the skin and has a low incidence of skin irritation. If finalized, the order will permit the use of bemotrizinol in adults and children beginning at 6 months.

The permitted dosage forms under the proposed order include oils, lotions, creams, gels, butters, pastes, ointments, sticks and certain nonpropellant or isolated-propellant spray formulations.

The proposed order for bemotrizinol represents a long-overdue milestone after decades of inaction. The FDA's accompanying statements acknowledge these historical delays and signal a clear commitment to further streamline and modernize the regulatory process for future sunscreen ingredients. Acting Director of the FDA's Office of Nonprescription Drugs, Dr. Karen Murry, stated that the reforms in the CARES Act have "greatly streamlined the monograph drug regulatory process," signaling the agency's readiness to work with sponsors on other new active ingredients. The FDA is now accepting public comments on the proposed order until Jan. 26, 2026, which is the next step before a final administrative order can be issued to amend the monograph.

Continuing Resolution Sunscreen Provisions: Additional Reforms

Building on the procedural modernization of the CARES Act, the recently enacted continuing resolution (CR) implements substantive reforms to the scientific standards for sunscreen ingredient evaluation. These provisions, derived from the bipartisan H.R.3686 and S.2491, the SAFE Sunscreen Standards Act, amend Section 505G of the Federal Food, Drug, and Cosmetic Act to address long-standing barriers related to testing requirements. The bipartisan sunscreen reforms were championed by Sens. Maggie Hassan (D-N.H.) and Dr. Roger Marshall (R-Kan.) and Reps. John Joyce (R-Pa.), Debbie Dingell (D-Mich.), David Joyce (R-Ohio) and Deborah Ross (D-N.C.). The legislative intent is to move the FDA beyond its rigid reliance on specific clinical trials, such as MUsT.

The new law directs the U.S. Department of Health and Human Services (HHS) Secretary to establish evidence and testing standards that allow for greater flexibility while maintaining rigorous safety standards. Specifically, the FDA must now permit the use of "real-world evidence," "observational studies" and other "scientifically valid approaches" to supplement or replace traditional clinical tests for demonstrating safety and effectiveness. Further, the legislation mandates that the FDA consider non-animal testing methods for evaluating sunscreen ingredients and requires the agency to issue new guidance for sponsors to enable use of other nonclinical testing alternatives within 180 days of the law's enactment. These reforms are designed not to lower safety standards, but to align the U.S. regulatory framework with modern scientific methodologies and international best practices, thereby fostering innovation while ensuring robust consumer protection.

Practical Implications

The combined effect of the CARES Act's procedural streamlining and CR's substantive testing reforms creates a significantly more favorable regulatory environment for sunscreen innovation. For manufacturers, the approval of bemotrizinol via the OMOR pathway validates the new process, while the CR's provisions open the door for more flexible and less burdensome data packages for both new and existing ingredients. It is expected that Americans will benefit from the availability of new and safer sunscreens.

All stakeholders – including manufacturers, public health organizations and industry groups – should closely monitor several key developments in the coming months such as the public comment period and subsequent final administrative order for bemotrizinol, which will serve as a template for future ingredient reviews. Moreover, the newly required FDA guidance on non-animal testing alternatives will be critical for shaping future data submissions.

Finally, stakeholders should watch for the FDA's annual reports to Congress on the implementation of these new standards, which will provide transparency on the agency's progress in modernizing the sunscreen monograph. This evolving landscape presents a crucial opportunity to collaborate with the FDA to ensure these reforms translate accordingly into timely access to a broader range of safe and effective sunscreens for American consumers.

For more information or questions, please contact the authors.

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