The SAFE Sunscreen Standards Act Could Accelerate Innovation and Improve Access
In June 2025, U.S. lawmakers introduced a bill that could mark a turning point in sunscreen regulation. The SAFE Sunscreen Standards Act (H.R. 3686) aims to streamline the U.S. FDA’s approval process for sunscreen ingredients, enabling quicker access to advanced sun protection and aligning regulatory practices with modern scientific standards.
Backed by the bipartisan Congressional Skin Cancer Caucus, the act proposes a series of reforms to address a long-standing issue: the lack of innovation in sunscreen actives approved for use in over-the-counter (OTC) products in the U.S., with no new filters added to the official monograph in nearly 25 years.
What the bill proposes
The SAFE Sunscreen Standards Act introduces three main pillars to improve the regulatory process:
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Improved Evaluation Standards
The FDA would be required to accept real-world evidence (RWE), observational studies, and non-animal testing methods to evaluate safety and effectiveness. This more flexible approach reflects current ethical and scientific expectations. -
Finalizing Long-Pending Ingredient Reviews
The act urges the FDA to issue final administrative orders for sunscreen ingredients already in use abroad, considering historical safety data alongside the updated testing standards. -
Greater Transparency
The Secretary of Health and Human Services would need to publish annual reports detailing the FDA’s progress under the new standards, including the number of applications reviewed and the use of non-animal testing approaches. These reports would be made publicly available on the FDA’s website.
Why does this matter for the global cosmetics industry?
Although this legislative effort is U.S.-based, its implications are global. Many sunscreen filters approved in Europe are still not permitted in the U.S., creating regulatory barriers and delaying market access to more effective protection technologies. Bemotrizinol, for instance—widely used in the EU—is still awaiting FDA approval, despite a formal application submitted by DSM-Firmenich.
Moreover, the shift toward alternative testing methods and flexible evidence models reflects a growing international trend. As advocates of cosmetic regulatory intelligence, we at Regulatory.cosmeticsinMind welcome this evolution toward a smarter, more transparent, and innovation-driven regulatory environment.
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