FDA approves bemotrizinol, first new U.S. sunscreen active ingredient in 25 years under CARES Act sunscreen rules
On June 9, 2026, the FDA approved bemotrizinol as a new OTC sunscreen active ingredient — the first U.S. addition in 25 years under the CARES Act monograph reforms — expanding options for broad‑spectrum sun protection and addressing long‑standing dermatologist and consumer demand.
- Regulatory milestone: The FDA issued a final order adding bemotrizinol to the OTC Sunscreen Monograph M020 as GRASE for ages 6 months and older — see the FDA press announcement.
- Formulation limits: Bemotrizinol is allowed up to 6% in lotions, creams, gels, sticks and certain sprays, matching Canada’s limit but below many other markets — per legal and trade analyses including HK Law and trade analysis.
- Market entry: DSM Nutritional Products will launch bemotrizinol as Parsol Shield and expects roughly 18 months of monograph exclusivity before other makers may market the ingredient under the monograph rules.
What the FDA did
The FDA used the CARES Act’s updated OTC monograph pathway — the streamlined OTC Monograph Order Request (OMOR) process — to amend Monograph M020 and add bemotrizinol as an approved sunscreen active. The agency proposed the change in December 2025, accepted public comments, and issued a final order on June 9, 2026; see the FDA proposed order and the final press announcement.
“This is the first active ingredient added through the OMOR process and a test case for future sunscreen innovation,” according to FDA materials.
Why bemotrizinol was approved: efficacy and safety
FDA reviewers found bemotrizinol provides broad‑spectrum UVA and UVB protection and is photostable, retaining protection when exposed to light. The agency concluded there is low skin irritation and low systemic absorption at the tested 6% concentration; reviewers cited clinical pharmacokinetic data showing plasma levels rarely exceeded the FDA’s 0.5 ng/mL threshold. For the scientific review, see the review article on modern UV filters and the FDA summary.
Regulatory conclusion: Based on the evidence, the FDA declared bemotrizinol GRASE for adults and children six months and older when used as labeled.
Allowable concentration, dosage forms and labeling
The final order permits bemotrizinol at concentrations up to 6% in OTC sunscreens. Permitted product forms include oils, lotions, creams, gels, butters, pastes, ointments, sticks and certain non‑propellant or isolated‑propellant sprays, provided the products meet all Monograph M020 requirements such as SPF and broad‑spectrum testing and compliant Drug Facts labeling. For context on allowed forms and comparison with other markets, see HK Law analysis and the trade/legal overview.
Who asked for it and how it reached approval
DSM Nutritional Products (now part of DSM‑Firmenich) filed a Tier 1 OMOR requesting bemotrizinol for use up to 6%, first submitting the request in September 2024. The FDA published a proposed order in December 2025, solicited public comments, and finalized the order in June 2026; details are available in the FDA announcement and the proposed order materials.
Market impact and exclusivity
DSM will market bemotrizinol initially as Parsol Shield and expects to introduce products later in 2026. Under the OMOR framework, the sponsor receives a time‑limited exclusivity period for the approved monograph use; trade analyses estimate roughly 18 months of exclusivity, after which other manufacturers may market bemotrizinol if they meet monograph standards. See industry commentary at Diaz Trade Law.
FDA leadership and regulatory framing
Agency leaders framed the approval as both a public‑health gain and evidence the FDA is modernizing OTC drug regulation after years of criticism about slow progress on new sunscreen ingredients. FDA officials emphasized expanded consumer choice while maintaining safety standards. Commissioner Marty Makary noted the agency historically moved too slowly on sunscreen ingredients; Acting Office of Nonprescription Drugs director Karen Murry described bemotrizinol as a welcome addition and signaled continued work to accelerate safe access to OTC innovations. Read the official messaging in the FDA press release.
International context and what it means for U.S. consumers
Bemotrizinol is widely used outside the U.S., particularly in Europe, where it has served as a modern UV filter offering strong UVA coverage and photostability. This U.S. approval narrows the gap between American and international sunscreen formulations many dermatologists prefer, though the U.S. 6% cap is lower than the 10% allowed in some markets, which could influence comparative product performance. For a technical review, see the scientific review.
FDA guidance and public health advice
The FDA emphasized sunscreens are one element of sun safety. The agency continues to recommend broad‑spectrum sunscreens with SPF 15 or higher, routine reapplication, shade and protective clothing, and limiting sun exposure during peak UV hours. The FDA will monitor market products containing bemotrizinol for safety and compliance; see the agency Q&A on the OTC sunscreen monograph.
Implications for the United States of America
Economic impact
New active chemistry typically drives reformulation, testing and manufacturing work. DSM’s Parsol Shield and follow‑on products could spur industry activity, creating jobs in product development and manufacturing and generating a wave of premium sunscreens marketed for better UVA protection.
Political consequences
The approval is a tangible outcome of the CARES Act OTC monograph reforms and offers talking points for lawmakers who backed the update. The 18‑month exclusivity window may prompt discussion about competition and market protections.
Social effects
For families and sun‑smart consumers, more options could improve UVA protection—important for aging and some skin‑cancer risks. Pediatric guidance already permits sunscreen use for children 6 months and older; bemotrizinol is now allowed in labeled products for that age group.
Cultural relevance
Americans who preferred European formulations have long sought comparable U.S. offerings. This approval may reduce that frustration and bring similar product choices to domestic shelves.
Practical applications
Shoppers should assess new products on broad‑spectrum labeling, SPF value, water resistance and clear Drug Facts. Expect Parsol Shield formulations in 2026 and competing products after the expected ~18‑month exclusivity. Meanwhile, continue proven sun safety: seek shade, wear protective clothing, and reapply sunscreen every two hours or after swimming or sweating.
Sources and further reading
- FDA press announcement: FDA expands sunscreen options for the first time in over 20 years
- FDA proposed order and related materials on expanding sunscreen active ingredients
- FDA Q&A on OTC sunscreen monograph changes
- Review article on modern UV filters including bemotrizinol
- Trade and legal analysis of market impact and exclusivity (Diaz Trade Law)
- HK Law: analysis of the proposed new sunscreen ingredient
