The U.S. Food and Drug Administration announced on December 11, 2025, a significant step toward modernizing sunscreen regulations by proposing the addition of bemotrizinol as an approved active ingredient in over-the-counter sunscreen products.
This marks the first proposed expansion of the FDA's sunscreen ingredient list in more than two decades, addressing long-standing concerns about the limited options available to American consumers compared to their international counterparts.
Bemotrizinol, known internationally by brand names including Tinosorb S and Parsol Shield, has been safely used in Europe, Australia, and parts of Asia for over 20 years. The ingredient represents a significant departure from the stagnant regulatory landscape that has characterized U.S.
sunscreen regulations since 1999. DSM Nutritional Products LLC submitted the request to add bemotrizinol at concentrations up to 6 percent as a new active ingredient in the over-the-counter monograph for sunscreens.
A Regulatory Shift Long Overdue
The status quo in American sunscreen regulations stands in sharp contrast to the global market. While the United States currently permits 16 principal active sunscreen ingredients, the European Union has approved approximately 30 to 34 different UV filters.
This disparity reflects fundamental differences in regulatory approaches between the two markets. European regulators classify sunscreens as cosmetics, enabling a more flexible approval pathway, whereas the FDA treats them as over-the-counter drugs requiring extensive premarket testing.
FDA Commissioner Marty Makary stated that the agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. The proposal is part of a broader initiative within the FDA's Office of Nonprescription Drugs to modernize the regulation of over-the-counter drug products.
Karen Murry, Acting Director of the Office of Nonprescription Drugs, described bemotrizinol as a welcome addition to the current array of effective sunscreen active ingredients available to American consumers.
Superior Protection and Broad-Spectrum Coverage
Bemotrizinol distinguishes itself from most currently approved U.S. chemical sunscreen filters through its ability to provide broad-spectrum protection against both ultraviolet A and B rays.
The vast majority of chemical filters currently approved in the United States offer protection against either UVA or UVB rays, and manufacturers must combine multiple ingredients to achieve comprehensive coverage.
As a chemical filter rather than a mineral-based filter like zinc oxide or titanium dioxide, bemotrizinol offers significant cosmetic advantages. Chemical filters are lighter, blend more easily into the skin, and do not leave the white residue associated with mineral sunscreens.
Bemotrizinol is exceptionally photostable, meaning it resists degradation when exposed to sunlight, whereas many currently approved chemical filters like avobenzone deteriorate significantly during sun exposure.
The molecular structure of bemotrizinol contributes to both its efficacy and safety profile. With an oil-soluble composition and large molecular size, the ingredient exhibits minimal skin penetration and low systemic absorption.
According to FDA review, bemotrizinol has been found to be the most effective UV absorber available when measured by sun protective factor, based on the maximum concentration permitted by European legislation.
Safety and Efficacy Assessment
The FDA's scientific evaluation focused on bemotrizinol's safety at concentrations up to 6 percent, the level proposed for use in American sunscreen products.
The agency reviewed comprehensive nonclinical data, including dermal carcinogenicity studies, developmental and reproductive toxicity studies, and clinical pharmacology evaluations.
A human maximal usage trial demonstrated that bemotrizinol is not readily absorbed through human skin, even with repeat application, with most plasma concentrations remaining below the limit of quantitation.
The FDA determined that the aggregate absorption falls well below the 0.5 ng/mL threshold used to evaluate systemic absorption risks.
Clinical safety studies submitted to the FDA included repeated insult patch tests, cumulative irritation assessments, and phototoxicity evaluations conducted across hundreds of study participants.
The agency determined that these studies provided sufficient evidence that repeat exposure to bemotrizinol does not cause irritation or elicit sensitization, photo-allergenic, or phototoxicity responses. Only one serious adverse event—appendicitis—was reported across all clinical studies, and it was not attributed to the study formulations.
For efficacy, the FDA reviewed human clinical studies demonstrating that bemotrizinol-containing formulations exhibit a concentration-related increase in SPF value, with all test product formulations exceeding the minimum SPF of 2.
If the FDA finalizes this proposal, bemotrizinol would be designated as generally recognized as safe and effective for use by adults and children 6 months of age and older, making it the third sunscreen ingredient deemed appropriate for use on infants, alongside zinc oxide and titanium dioxide.
International Context and Dermatological Support
The long international history of bemotrizinol use provides additional evidence supporting its safety profile. The ingredient has been marketed in multiple countries for over two decades without raising significant safety concerns.
Dermatologists have highlighted that bemotrizinol appears better tolerated than many existing U.S.-approved chemical filters, which at baseline can cause irritation in individuals with acne, rosacea, or eczema. The improved tolerability may enhance consumer compliance with sunscreen use, a critical factor in preventing skin cancer.
Dr. Michelle Henry, a dermatologist contributing to medical commentary, noted that bemotrizinol fills gaps in the sun protection spectrum currently available through U.S.-approved products. Dr.
Steven Wang observed that bemotrizinol does not penetrate the body surface or enter the bloodstream, supporting a favorable safety profile. These professional assessments indicate broad support within the dermatology community for the ingredient's addition to the approved list.
Implications for the Sunscreen Industry
The approval of bemotrizinol would enable significant innovation in sunscreen formulations. Industry chemists have noted that the limited array of approved filters in the United States has constrained their ability to develop improved sunscreen textures and delivery systems.
With access to bemotrizinol, manufacturers could create lighter, more elegant formulations that are easier to apply and more comfortable for daily use—factors that encourage consistent sunscreen application and better protection outcomes.
Many major sunscreen manufacturers already have bemotrizinol formulations in use internationally and could potentially bring these products to the U.S. market following final FDA approval. However, bringing formulations to market requires laboratory expertise and dedicated resources to ensure that sunscreen products maintain adequate UV protection throughout their entire shelf life.
Even with bemotrizinol's superior photostability, sunscreens containing the ingredient typically require additional stabilizers and complementary filters to achieve sufficient protection levels.
Timeline and Next Steps
The FDA's announcement initiates a 45-day public comment period during which interested parties can submit data, scientific information, and recommendations regarding bemotrizinol's safety and effectiveness.
FDA representatives indicated that the timeline for a final decision will depend substantially on feedback received during the comment period. The agency is targeting summer or fall 2026 for issuance of a final order, which could enable manufacturers to begin marketing bemotrizinol-containing products as early as late 2026.
The public comment period represents a critical juncture in the approval process, as the FDA will evaluate all submitted information before issuing its final determination.
If the agency concludes that bemotrizinol is generally recognized as safe and effective as a sunscreen active ingredient, it will issue a final order adding the ingredient to OTC Monograph M020.
Broader Regulatory Reform Context
The bemotrizinol proposal reflects wider efforts to modernize the FDA's approach to over-the-counter drug regulation. The Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, enacted in 2020, transformed the FDA's monograph system from a traditional rulemaking process to an administrative order process.
This reform has streamlined the regulatory pathway for updating and expanding over-the-counter drug monographs, enabling more rapid responses to new scientific data and changed regulatory conditions.youtube
Dr.
Karen Murry emphasized that the reforms contained in the CARES Act have greatly streamlined the monograph drug regulatory process and expressed the FDA's intention to work with other companies on bringing products containing additional new active ingredients to market in multiple therapeutic areas in a more timely fashion than was previously possible.
The Sunscreen Innovation Imperative
The United States faces an epidemic of skin cancer and related dermatological conditions, with dermatologists emphasizing the critical importance of improving sunscreen products and consumer access to more effective options.
The proposed addition of bemotrizinol addresses a fundamental limitation in the current regulatory framework that has inhibited innovation and left American consumers at a disadvantage compared to those in other developed nations.
The FDA's proposal signals a recognition that the regulatory status quo—unchanged for 26 years—no longer serves public health interests. By enabling access to a superior sunscreen ingredient that has established a strong safety record across multiple international markets, the agency aims to expand consumer choice and support improved sun protection practices.
The approval of bemotrizinol would likely catalyze broader regulatory changes, establishing a pathway for evaluation and approval of other internationally recognized sunscreen ingredients that could further enhance the protection options available to American consumers.
