Is Zinc Oxide Safe in Sunscreen?
The FDA has proposed that it is, but has not finalized that. In its February 2019 proposed sunscreen rule, the FDA said its review produced sufficient safety data on zinc oxide and titanium dioxide to support a proposal that sunscreens containing them at up to 25 percent would be generally recognized as safe and effective (GRASE), and its sunscreen questions and answers page, current as of September 10, 2026, still describes that as a proposal.
On absorption, the FDA noted in 2019 that nanoscale zinc oxide can be solubilized to a small extent under conditions achievable on the skin, but said the amount potentially absorbed is de minimis and far lower than daily nutritional intake of zinc. In the EU, the Scientific Committee on Consumer Safety concluded in 2012 that zinc oxide nanoparticles meeting its specifications, at up to 25 percent as a UV filter, can be considered not to pose a risk of adverse effects after application to the skin, but said this does not apply to uses that might lead to inhalation, such as sprayable products.
The FDA has finalized other parts of its sunscreen review in 2026. In June it added bemotrizinol at up to 6 percent as a sunscreen active ingredient, and on September 10 it issued a final order finding PABA and trolamine salicylate not GRASE and removing them, saying it will address its other 2021 proposals in future orders.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Regulatory filingIn its February 2019 proposed rule, the FDA said it had sufficient safety data on zinc oxide and titanium dioxide to support a proposal that sunscreens containing them at up to 25 percent would be GRASE. US FDA, Federal Register ↗
- Government sourceThe FDA said in 2019 that nanoscale zinc oxide can be solubilized to a small extent at pH levels achievable on the skin, but the amount potentially absorbed is de minimis and far lower than daily nutritional zinc intake. US FDA, Federal Register ↗
- Government sourceThe FDA's sunscreen Q&A says its review found sufficient safety data on zinc oxide and titanium dioxide to support a proposal that sunscreens containing them at up to 25 percent are GRASE. US FDA ↗
- Regulatory filingThe FDA says its September 10, 2026 final order finds PABA and trolamine salicylate not GRASE for sunscreens and removes them from OTC Monograph M020, and that it will address its other 2021 proposals in future orders. US FDA ↗
- Regulatory filingIn June 2026 the FDA announced a final order amending OTC Monograph M020 to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. US FDA, Federal Register ↗
- Government sourceThe SCCS concluded in 2012 that specified zinc oxide nanoparticles at up to 25 percent as a sunscreen UV filter can be considered not to pose a risk after dermal application, but not for uses that may be inhaled, such as sprays. EU Scientific Committee on Consumer Safety ↗
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.