Written on: February 1, 2026 by Nicholas Georges
The Winter season often coincides with travel to warmer destinations to escape the cold, where higher UV exposure makes effective sun protection essential, including the use of aerosol sunscreen products.
In the U.S., aerosol sunscreens are regulated by the Food & Drug Administration (FDA) as an over-the-counter (OTC) drug rather than as a cosmetic product. Companies can bring new aerosol sunscreen products to market without approval by the FDA by following the OTC Monograph,i which specifies the permitted active ingredients and their concentrations, labeling and testing procedures. Products that meet all of the OTC Monograph requirements are considered “Generally Recognized As Safe and Effective” (GRASE). It’s important to note that, in recent years, the FDA has raised concerns about inhalation risk to spray sunscreen products, including aerosols;ii however, the Household & Commercial Products Association (HCPA) and other industry stakeholders have disputed these concerns.iii
The next time you find yourself in the sun, remember the importance of sunscreen and the dedicated efforts by companies to ensure that these products are safe and effective.
Many newer UV filters used globally are not currently approved in the U.S. Recently, the FDA proposediv amending the OTC Monograph for sunscreens to include bemotrizinol at concentrations up to 6% as an active ingredient. This marks the first proposed addition of a new UV filter by the FDA in more than two decades. While the proposal represents an important step toward expanding available active sunscreen ingredients in the U.S., key stakeholders, such as the Personal Care Products Council (PCPC), continue to advocate for an accelerated pathway for the FDA to approve additional active ingredients for the U.S. market.
Manufacturers and marketers of aerosol sunscreens should be aware of State-level regulations that could impact the distribution and sale of products. Most notably, Hawaii’s sunscreen lawv bans products containing oxybenzone and/or octinoxate. The Hawaiian county of Maui goes even further,vi prohibiting all non-mineral active ingredients.
Companies should also be aware that aerosol sunscreen was included in the California Air Resources Board’s (CARB) most recent product survey. While inclusion in the survey does not necessarily mean that CARB will create a future standard for these products, Industry should prepare for it to be discussed.
HCPA, PCPC and allied trade associations, including the Consumer Healthcare Products Association (CHPA) and the National Aerosol Association (NAA), plan to host industry-wide meetings to discuss all 37 product categories being surveyed by CARB. These discussions aim to ensure that the draft aggregate summary data is as accurate as possible when it becomes available, especially since Industry will have only one opportunity to review the draft data.
Once final, the aggregate summary data will serve as the foundation for any emission reductions that CARB pursues and provide the basis for volatile organic compound (VOC) equivalency determinations as CARB develops new standards using maximum incremental reactivity (MIR).
If interested in aerosol sunscreen products or you would like to participate in Industry’s review of CARB’s draft aggregate summary data, please contact me at ngeorges@thehcpa.org. SPRAY
i 21 CFR Part 352
ii link
iii link
iv link
v HI Rev Stat § 342D-21
vi link
