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FDA moves forward with expanding the list of active ingredients for sunscreens
- Daniel Jiménez
- 3 hours ago
- 2 min read
The U.S. Food and Drug Administration (FDA) has published a proposal to expand the list of permitted active ingredients in over-the-counter (OTC) sunscreens in the United States. This initiative is part of the agency's efforts to update the regulatory framework for sun protection and evaluate UV filters with a proven track record of use in other international markets.
Table of contents
What does the FDA's proposal entail?
The FDA is evaluating the possible inclusion of bemotrizinol, an organic UV filter, within the OTC monograph of sunscreens.
Preliminary scientific review
It provides broad-spectrum protection against UVA and UVB radiation.
It exhibits high photostability, helping to maintain the product's effectiveness after sun exposure.
It shows low systemic absorption after topical application, according to the studies evaluated.
It has a long history of use outside the United States, especially in advanced sun protection formulations.
Regulatory framework for sunscreens in the United States
In the United States, sunscreens are subject to a specific regulatory framework as OTC products, which means that only active ingredients expressly included in the corresponding monograph can be used.
Unlike other markets such as the European Union, Australia, or Japan, the list of authorized UV filters in the U.S. has remained virtually unchanged for decades. This situation has limited innovation in formulation and hindered the harmonization of products globally.
The possible incorporation of bemotrizinol would therefore represent a significant step towards updating the list of UV filters available on the US market, bringing it closer to regulatory standards already established in other regions.
Conclusion
The FDA's proposal to expand the list of active ingredients in sunscreens reflects a gradual step toward modernizing the U.S. regulatory framework for sun protection. While still in its preliminary stages, this development is particularly relevant for brands, formulators, and regulatory teams planning their entry into or expansion within the U.S. market.
At Belab Services, we continuously monitor these types of initiatives and support our clients in the regulatory assessment and compliance of OTC products , both in the United States and in other international markets.
