What is the FDA approval of bemotrizinol and why does it matter?
The FDA approved bemotrizinol (BEMT) as a new over the counter (OTC) sunscreen active ingredient in June 2026, marking the first new sunscreen filter added to the U.S. monograph system in over 20 years. The broad-spectrum, photostable UV filter provides UVA/UVB protection, is safe and effective at concentrations up to 6%, and will support more advanced sunscreen formulations in the U.S. market.
When did the FDA approve bemotrizinol as a new OTC sunscreen active ingredient?
In a landmark regulatory decision, the U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT) as a new active ingredient for over-the-counter (OTC) sunscreen products. The agency issued Final Administrative Order OTC000039 in June 2026, amending OTC Monograph M020 and marking the first addition of a new sunscreen active ingredient to the U.S. monograph system in more than two decades.
What is bemotrizinol and how does it protect against UVA and UVB rays?
Bemotrizinol is a broad-spectrum UV filter that provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. Already widely used in Europe, Asia, and other international markets since the late 1990s, the ingredient is recognized for its excellent photostability, meaning it remains effective during prolonged sun exposure without significant degradation.
Why did the FDA determine that bemotrizinol is safe and effective for sunscreen use?
The FDA concluded that bemotrizinol is generally recognized as safe and effective (GRASE) for use in sunscreen products at concentrations up to 6%.
According to the Agency, available data demonstrate:
- Low dermal absorption.
- A favorable toxicological profile.
- Minimal potential for skin irritation.
How will FDA approval of bemotrizinol impact sunscreen formulations in the United States?
The approval is expected to expand formulation possibilities for sunscreen manufacturers, enabling the development of products with enhanced UVA protection and improved cosmetic elegance. Dermatologists and industry stakeholders have long advocated for the inclusion of modern UV filters in the U.S. market, noting that regulatory barriers had limited innovation compared with other regions.
When will consumers be able to buy sunscreens containing bemotrizinol in the U.S.?
Initially, products containing bemotrizinol are expected to be marketed under DSM-Firmenich’s PARSOL® Shield technology, with broader market access anticipated after the exclusivity period expires. The decision is widely viewed as a significant step toward modernizing U.S. sunscreen regulations and improving consumer access to advanced sun protection technologies.
Key takeaways: FDA approval of bemotrizinol modernizes OTC sunscreen options and expands UV protection innovation
The FDA approved bemotrizinol (BEMT) in June 2026 through Final Administrative Order OTC000039, updating OTC Monograph M020 with a new OTC sunscreen active ingredient. The broad-spectrum UV filter provides UVA/UVB protection, excellent photostability, and was deemed safe and effective up to 6%, enabling more advanced sunscreen formulations in the U.S. market.
