June 9, 2026, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
The FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, M.D., Ph.D., Acting Director of the FDA Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.
Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act. Today’s action aligns with the Make America Healthy Again (MAHA) Strategy Report priority, "FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries."
“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, M.D., Director of the Office of Nonprescription Drugs in CDER. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”
An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order, and a drug company may start the process by submitting an OTC monograph order request.
DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient. The agency issued a proposed order on December 12, 2025, to this effect, and the public could submit comments from December 12, 2025 - January 26, 2026. The agency reviewed public comments on the proposed order and is now issuing the final order.
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An unofficial translation of this announcement is provided below.
翻译参考：
FDA 二十年来首次扩大防晒霜产品范围
2026年6月9日，美国食品药品监督管理局（FDA）将双-乙基己氧苯酚甲氧苯基三嗪（Bemotrizinol）列入获批防晒霜活性成分名单，这标志着FDA推动防晒产品创新工作迈出了重要的里程碑式的一步。Bemotrizinol是自20世纪90年代末以来，首个被纳入非处方药（OTC）防晒霜专论的新活性成分。
"正如特朗普政府《让美国再次健康（MAHA）战略报告》中所承诺的，美国卫生与公众服务部（HHS）正通过推动创新，将20年来首个新防晒成分引入美国市场，"HHS部长小罗伯特·F·肯尼迪表示。" Bemotrizinol在欧洲已安全使用数十年，FDA的此次行动将有助于增强市场竞争，并提升消费者对防晒产品的信心。"
FDA在发布拟议令后的七个月内便完成了这一最终决定。该新成分多年来已在欧洲及全球众多国家作为防晒成分上市销售。
"当我们推进流程现代化、将严谨的科学应用于监管决策时，正是能够取得此类进展的时候，"FDA药品评估与研究中心（CDER）代理主任Mike Davis博士表示。"FDA致力于确保美国消费者能够获得最有效、最安全的治疗产品，包括防晒霜等非处方药品。"
Bemotrizinol能够同时防护紫外线A（UVA）和紫外线B（UVB），且经皮肤吸收进入人体的水平较低。FDA认定，Bemotrizinol用于成人及6个月以上儿童的防晒产品中，符合"普遍认为安全有效（GRASE）"的标准。
Bemotrizinol是依据《CARES法案》所建立的简化程序，首个被纳入OTC专论的新活性成分。此次行动契合《让美国再次健康（MAHA）战略报告》的优先事项，即"FDA将推动防晒产品市场创新，并改善非处方防晒霜的监管流程，以跟上其他国家的步伐。"
"FDA严格的标准确保消费者能够对其所使用的防晒霜和其他非处方药品充满信心，"CDER非处方药办公室主任Karen Murry博士表示。"如今，借助最先进的科学手段和更新的监管框架，我们能够以前所未有的高效方式与企业合作，将创新产品推向市场。"
OTC专论药品（如防晒霜）在满足特定要求的前提下——包括符合其专论规定的获批活性成分、适用范围和剂量等条件——无需经药品申请批准即可进入市场。FDA可通过行政令修订OTC专论，药品企业亦可通过提交OTC专论令申请启动相关程序。
DSM营养产品有限责任公司（DSM Nutritional Products LLC）提交了OTC专论令申请，申请将Bemotrizinol（浓度上限为6%）作为新活性成分纳入防晒霜OTC专论。FDA对该申请进行了审查，并提议修订OTC专论，将Bemotrizinol列为防晒霜活性成分。FDA于2025年12月12日发布拟议令，公众可在2025年12月12日至2026年1月26日期间提交意见。FDA对拟议令的公众意见进行了审查，现正式发布最终命令。
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Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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