FDA Moves to Add bemotrizinol to U.S. Sunscreen Options — First New Active Ingredient in Over 25 Years
The FDA has proposed adding bemotrizinol to the U.S. sunscreen monograph — the first new active ingredient in more than 25 years — potentially bringing the widely used UVA/UVB filter to American shoppers by 2026 if finalized.
Key takeaways
- Proposed addition: The FDA has proposed expanding the U.S. list of sunscreen active ingredients to include bemotrizinol, a broad‑spectrum UV filter used in many countries — see the FDA press release.
- Safety profile: The agency notes low skin absorption and rare irritation for bemotrizinol, supporting its potential general recognition as safe and effective if finalized (FDA).
- Market timing and exclusivity: DSM plans to market bemotrizinol as Parsol Shield in the U.S. in late 2026, with an expected 18‑month exclusivity period (see AP reporting via video).
Main story
Key information
The FDA on Tuesday proposed expanding the list of sunscreen active ingredients to include bemotrizinol, a broad‑spectrum UV filter that has been used for years in other countries. The agency emphasized the chemical’s ability to protect against both UVA and UVB rays while demonstrating low skin absorption and rare irritation (FDA press release).
Dutch company DSM Nutritional Products has requested approval for bemotrizinol at concentrations up to 6% in over‑the‑counter sunscreens and plans to market the ingredient in the U.S. under the name Parsol Shield. DSM’s application and related reporting indicate a planned U.S. launch in late 2026, followed by an 18‑month exclusivity period before competitors can use the filter (AP reporting via video).
What the FDA said about bemotrizinol
The agency’s proposed order highlights bemotrizinol’s stable, broad‑spectrum protection and low potential for systemic absorption and irritation. The FDA noted that bemotrizinol is marketed in many countries but has not previously been approved for use in U.S. drug products (FDA).
Marty Makary, MD, MPH, FDA Commissioner: “We’re continuing to modernize the regulation of sunscreen and other over‑the‑counter drug products. Americans deserve timely access to the best safe, effective and consumer‑friendly over‑the‑counter products available.” (FDA)
Karen Murry, MD, Acting Director, Office of Nonprescription Drugs: bemotrizinol “would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” and the agency signaled intent to accelerate review of future active ingredients (FDA).
Why this matters for consumers
If the proposed order is finalized, bemotrizinol would expand consumer choice with a filter many dermatologists abroad consider modern and photostable compared with some older U.S. options. Markets outside the United States already use newer filters such as bemotrizinol, which can offer broader protection and greater stability under sunlight (review).
The FDA continues to recommend a layered approach to sun safety: use broad‑spectrum sunscreens with SPF 15 or higher, wear protective clothing, and limit time in direct sun. Any new ingredient must meet the agency’s safety and effectiveness standards before broad availability (FDA).
Timing, exclusivity and marketplace effects
DSM’s plan to sell bemotrizinol as Parsol Shield is expected to begin in late 2026, with an 18‑month exclusivity period that could limit initial competition and affect pricing and availability. From a regulatory standpoint, exclusivity rewards investment in safety and efficacy testing, but from a market perspective it can concentrate early sales with a single company (AP reporting via video).
The FDA’s proposed order requires public comment before a final decision, allowing industry rivals, consumer groups and health experts to weigh in on safety and market‑access implications (FDA).
Safety and effectiveness standards
The FDA’s proposal states bemotrizinol would be generally recognized as safe and effective for adults and children 6 months and older if a final order is issued — the agency’s standard for clearing active ingredients for over‑the‑counter use (FDA).
In its review, the FDA cited data showing low systemic absorption and rare irritation — important considerations given earlier public concern about sunscreen ingredients entering the bloodstream. Experts have noted the U.S. lag has left consumers with fewer filter options than in Europe and elsewhere; bemotrizinol would be the first expansion of approved actives in over 25 years, adding to roughly 16 filters currently recognized in the U.S. framework (review).
Regulatory process and next steps
This action is a proposed order. The FDA must review public comments, complete administrative steps, and issue a final order before bemotrizinol can be formally added to the monograph and used generally in over‑the‑counter sunscreens. DSM specified a maximum concentration of 6%, and the FDA’s evaluation considered that limit in judging safety and effectiveness (FDA).
Commissioner Makary framed the decision as part of a broader modernization of OTC drug regulation, signaling a shift toward faster evaluations that could change how quickly future filters reach the U.S. market (FDA).
Implications for the United States of America
Economic impact: Approval could create opportunities for manufacturers, retailers and suppliers tied to sunscreens and personal care products. Parsol Shield’s entry could spur new manufacturing contracts and marketing efforts, though the 18‑month exclusivity may concentrate early profits with DSM and its partners (AP reporting via video; FDA).
Political consequences: Conservatives favoring regulatory reform may view the FDA’s action as evidence of faster approvals and reduced barriers to products Americans use abroad; Commissioner Makary’s comments respond to criticism that the agency has been slow to update sunscreen regulation (FDA).
Social and cultural effects: Expanded sunscreen options could improve protection for outdoor workers, families and recreational users if bemotrizinol proves more effective or longer‑lasting. Adding a widely used European filter aligns U.S. choices more closely with international standards, a change with practical and cultural relevance.
Practical application: If the final order is issued, consumers may see Parsol Shield and other bemotrizinol‑containing sunscreens on shelves by late 2026. Until then, shoppers should watch labels for active ingredients and follow FDA guidance on broad‑spectrum protection and SPF levels (FDA).
Sources for further reference
- FDA press announcement on bemotrizinol
- Review of sunscreen ingredients and regulation
- Reporting tied to DSM’s planned U.S. launch and exclusivity (AP reporting via video)
The FDA’s proposed addition of bemotrizinol opens a new chapter in U.S. sunscreen regulation, bringing an ingredient long used overseas into the national conversation about safety, access and market competition while leaving final approval contingent on public comment and administrative review.
