Is Octinoxate Safe?
The FDA says the record is incomplete. In its 2019 proposed sunscreen rule, it placed octinoxate in Category III, along with ingredients including homosalate, oxybenzone and avobenzone, because the public record did not contain sufficient data to support a positive determination that it is generally recognized as safe and effective. The FDA noted that octinoxate was one of only three such ingredients that appear to have been evaluated in human absorption studies, that most of those studies had significant limitations, and that even with limited exposure some showed systemic availability of octinoxate.
A 2020 study in JAMA measured it. It reported octinoxate blood plasma concentrations of 7.9 ng/mL with a nonaerosol spray and 5.2 ng/mL with a pump spray, and concluded that all six tested active ingredients were systemically absorbed at levels above the FDA threshold for potentially waiving some additional safety studies. The authors wrote that these findings do not indicate that people should refrain from using sunscreen, and the FDA says its proposal on ingredients with insufficient data is not a conclusion that they are unsafe.
Hawaii acted on its own. Its law makes it unlawful, beginning January 1, 2021, to sell, offer for sale or distribute for sale in the state any sunscreen containing oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Regulatory filingIn its 2019 proposed rule, the FDA placed octinoxate in Category III, with homosalate, oxybenzone and avobenzone among others, because the public record lacked sufficient data to support positive GRASE determinations. US FDA, Federal Register ↗
- Government sourceThe FDA said octinoxate appeared to be one of only three such ingredients evaluated in human absorption studies, most with significant limitations, and some showed systemic availability of octinoxate. US FDA, Federal Register ↗
- StudyA 2020 JAMA study reported octinoxate plasma concentrations of 7.9 ng/mL for a nonaerosol spray and 5.2 ng/mL for a pump spray. JAMA, via PubMed Central ↗
- StudyThe JAMA authors concluded all 6 tested sunscreen ingredients were systemically absorbed above the FDA threshold for potentially waiving some safety studies, and said the findings do not indicate that people should refrain from using sunscreen. JAMA, via PubMed Central ↗
- Government sourceThe FDA says its 2021 proposed order does not represent a conclusion that sunscreen ingredients proposed as having insufficient data are unsafe, and that it requested more information to evaluate their GRASE status. US FDA ↗
- Regulatory filingHawaii law makes it unlawful, beginning January 1, 2021, to sell or distribute for sale in the state any sunscreen containing oxybenzone or octinoxate without a prescription from a licensed healthcare provider. Hawaii Revised Statutes section 342D-21 ↗
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.