On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued a landmark regulatory decision—Final Administrative Order OTC000039. This order officially amends Over-the-Counter (OTC) Sunscreen Monograph M020 to approve the use of the brand-new sunscreen active ingredient Bemotrizinol (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) in OTC sunscreens at a maximum allowable concentration of 6%.
This marks the first time in over two decades that a truly modern, innovative chemical UV filter has been added to the U.S. sunscreen monograph, signaling a monumental milestone for the American sun care market.
I. What Did the FDA Declare?
According to the comprehensive 35-page final administrative order, the FDA thoroughly reviewed voluminous scientific safety data and public comments submitted by the requesting manufacturer, DSM Nutritional Products. The agency formally concluded that Bemotrizinol is Generally Recognized as Safe and Effective (GRASE) for use as a sunscreen active ingredient at concentrations up to 6%.
II. Two Core Foundations of the FDA’s Conclusion
The FDA’s landmark determination relies directly on rigorous data proving both clinical efficacy and systemic safety:
- Efficacy: Two independent human clinical efficacy trials successfully demonstrated that Bemotrizinol provides exceptional broad-spectrum UV protection at concentrations up to 6%.
- Safety: Through extensive non-clinical assessments, clinical pharmacology trials, and human safety monitoring, the FDA confirmed that Bemotrizinol at a 6% concentration exhibits minimal systemic skin absorption and is completely safe for adults and children aged 6 months and older.
III. Key Parameters: What Do Bemotrizinol Sunscreens Look Like?
Under the newly amended conditions of Monograph M020, any sunscreen product formulating with Bemotrizinol must strictly satisfy the following criteria:
- Maximum Concentration: Capped at 6.0%.
- Baseline SPF Value: The final product formulation must yield an SPF value of not less than 2.
- Permitted Dosage Forms: Bemotrizinol can be formulated into the following approved OTC formats:
- Oils, Lotions, Creams, Gels, Butters, Pastes, Ointments, and Sticks.
- Sprays: With a critical restriction. Sprays are permitted only if they are completely propellant-free (such as mechanical pump sprays) or utilize a continuous spray mechanism where the propellant is completely isolated from the sunscreen liquid (such as Bag-on-Valve (BoV) systems). Standard aerosol sprays where propellants mix directly with the formulation are currently prohibited due to insufficient long-term stability data.
Combination Rules & Contraindications
| Permitted Combinations | Prohibited Combinations (Contraindications) |
| Can be freely combined with most existing approved filters (e.g., Avobenzone, Homosalate, Octisalate, etc.) as well as specific skin protectants (e.g., Aloe vera, Petrolatum). | ABSOLUTELY BANNED from being blended with Aminobenzoic Acid (PABA) or Trolamine Salicylate, both of which carry unresolved safety concerns under the FDA’s broader monograph reviews. |
IV. Impact on Consumers and the Cosmetics Industry
- For Consumers: American consumers will soon have access to significantly more advanced, photostable, and cosmetically elegant sunscreens. Bemotrizinol is globally renowned for its smooth UV absorption curve and outstanding photostability—meaning it does not easily degrade when exposed to intense sunlight, ensuring longer-lasting and more balanced broad-spectrum coverage without leaving a greasy residue or severe white cast.
- For the Industry: This decision breaks a decades-long bottleneck in U.S. sun care innovation. Global beauty brands that previously could not launch their highly successful international formulations in the U.S. can now re-route their product pipelines. R&D and QA teams must quickly recalibrate their formulations to comply with the FDA’s specific rules, particularly the technical restrictions governing spray delivery systems.
V. Market Exclusivity and Effective Date
- 18-Month Market Exclusivity: As the primary requestor who spearheaded and funded the extensive data submissions, DSM Nutritional Products (and its authorized affiliates/assignees) has been granted an 18-month exclusive marketing right. During this initial 18-month window, only products utilizing DSM’s proprietary Bemotrizinol supply can be legally marketed in the United States.
- Effective Date: Final Administrative Order OTC000039 will officially take effect on August 9, 2026.
VI. Summary
The FDA’s approval of Bemotrizinol is a historic breakthrough in the sun care sector. It not only broadens the toolkit of protective options for U.S. consumers but also proves that the streamlined regulatory pathways introduced by recent legislative reforms are fully operational. For cosmetic exporters and global brands, the time to prepare for the comprehensive upgrade of the U.S. sunscreen market is now!
