WASHINGTON, D.C., United States, June 9, 2026
The U.S. Food and Drug Administration (FDA) has approved the addition of bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products, marking the first expansion of approved sunscreen ingredients in the United States in more than 20 years. The landmark regulatory decision represents a significant advancement for sunscreen innovation and consumer health protection, providing manufacturers with access to a widely used ultraviolet (UV) filter that has been available in Europe and numerous international markets for decades. FDA officials concluded that bemotrizinol is Generally Recognized as Safe and Effective (GRASE) for use in sunscreen products by adults and children six months of age and older. The action reflects growing efforts to modernize the U.S. sunscreen regulatory framework and expand access to advanced sun protection technologies that can help reduce exposure to harmful ultraviolet radiation associated with skin cancer, premature aging, and other dermatological conditions.
Bemotrizinol Expands Protection Against Harmful UV Radiation
The newly approved ingredient, bemotrizinol, offers broad-spectrum protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation, making it one of the most comprehensive sunscreen filters available globally. UVA rays are primarily associated with skin aging, pigmentation changes, and long-term skin damage, while UVB rays are the primary cause of sunburn and contribute significantly to skin cancer risk. According to the FDA’s review, bemotrizinol demonstrates low levels of absorption through the skin and has established a substantial safety record through years of international use. The ingredient can be incorporated into sunscreen formulations at concentrations of up to 6 percent, providing manufacturers with additional flexibility when developing high-performance sun protection products.
Industry experts believe the inclusion of bemotrizinol may enable the development of more effective broad-spectrum sunscreens with improved photostability, allowing products to maintain protective performance during prolonged sun exposure. The decision is expected to increase competition within the sunscreen market while giving consumers access to newer formulations that have already become widely adopted in Europe and other regions.
Regulatory Modernization Accelerates Sunscreen Innovation
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The FDA’s decision also represents a major milestone in regulatory modernization. Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined framework established by the CARES Act, which was designed to improve the efficiency of reviewing and updating nonprescription drug regulations. The process began when DSM Nutritional Products submitted an OTC Monograph Order Request seeking approval for the ingredient. Following a scientific review, the FDA issued a proposed order in December 2025, opened a public comment period, evaluated stakeholder feedback, and finalized the decision in June 2026.
Regulatory officials highlighted the action as an example of how modernized review pathways can support innovation while maintaining rigorous standards for safety and effectiveness. The approval aligns with broader federal initiatives focused on enhancing public access to innovative healthcare products and improving regulatory responsiveness to scientific advances.
Growing Demand for Advanced Sun Protection Technologies
The approval arrives as awareness of skin cancer prevention and sun safety continues to grow worldwide. Dermatologists and public health organizations consistently emphasize the importance of broad-spectrum sunscreen use as a key component of skin cancer prevention strategies. By expanding the list of approved sunscreen ingredients, the FDA is helping encourage innovation within the personal care and dermatology sectors while supporting consumer demand for more advanced protective products. The addition of bemotrizinol may also encourage further investment in sunscreen research and development, particularly as manufacturers seek to improve efficacy, cosmetic performance, and long-term skin protection.
As climate change, increasing UV exposure, and growing public awareness continue to drive interest in sun protection, regulatory actions supporting scientifically validated sunscreen innovation are expected to play an increasingly important role in global public health. The FDA’s latest decision therefore represents not only a regulatory milestone but also a significant step forward in advancing preventive skin health for millions of consumers.
Source: FDA press release
