What Does the FDA Say About Oxybenzone in Sunscreen?
The FDA says it needs more data. Its 2021 proposed order does not propose recognizing sunscreens containing oxybenzone as generally recognized as safe and effective, because additional data are needed, while it does propose that status for zinc oxide and titanium dioxide. The FDA stresses that this is not a conclusion that the ingredients lacking data are unsafe for use in sunscreens. On September 10, 2026 the FDA finalized one part of that proposal, removing PABA and trolamine salicylate from over-the-counter sunscreens, and it says it will address the remaining provisions in future orders.
The question is absorption. The FDA wrote that studies indicate oxybenzone is absorbed through the skin and can lead to significant systemic exposure, with data showing it in urine and blood plasma, and that this is a concern partly because of questions in the published literature about potential endocrine activity.
Hawaii has made it unlawful since January 1, 2021 to sell or distribute sunscreen containing oxybenzone or octinoxate without a prescription from a licensed healthcare provider.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Government sourceIn its 2021 proposed order the FDA wrote that studies indicate oxybenzone is absorbed through the skin and can lead to significant systemic exposure, with data showing it in urine and blood plasma. US FDA ↗
- Government sourceThe FDA wrote that oxybenzone’s significant systemic availability, and a lack of data on its full absorption, is a concern partly because of questions in the published literature about potential endocrine activity. US FDA ↗
- Government sourceThe FDA says there is evidence that at least some sunscreen active ingredients are absorbed through the skin, and that it has requested data from industry on their safety. US FDA ↗
- Regulatory filingThe FDA’s 2021 proposed order proposes that sunscreens containing oxybenzone and 11 other active ingredients are not generally recognized as safe and effective because additional data are needed. US FDA ↗
- Government sourceThe FDA says its 2021 proposed order does not represent a conclusion that the sunscreen ingredients proposed as having insufficient data are unsafe for use in sunscreens. US FDA ↗
- Regulatory filingOn September 10, 2026 the FDA issued a final order removing PABA and trolamine salicylate from over-the-counter sunscreens, and it says it will address the remaining provisions of its 2021 proposed order in future orders. US FDA ↗
- Regulatory filingHawaii’s Act 104 of 2018 made it unlawful, beginning January 1, 2021, to sell sunscreen containing oxybenzone or octinoxate without a prescription from a licensed healthcare provider. Hawaii State Legislature ↗
Sources checked September 15, 2026. A brand statement is the company’s own claim, which we report but have not verified. Our grades are model-based estimates, not lab tests.