A new peer-reviewed review article in Critical Reviews in Toxicology confirms that the UV filter octocrylene is considered safe for consumers when used in sunscreens products at concentrations up to 10%, which is consistent with existing global regulatory safety acceptance and approval of the ingredient.

The paper was recently shared by the Personal Care Products Council here.

Study Details

A comprehensive review was conducted of existing toxicity and consumer exposure data for the ultra-violet (UV) filter octocrylene (2-ethylhexyl-2-cyano-3,3-diphenylacrylate) as currently used in over-the-counter sunscreen formulations. Octocrylene has a long history of safe use, and there are sufficient in vitro studies, in vivo toxicity studies in animal models, and clinical data to characterize octocrylene’s pharmacokinetics, pharmacodynamics, and potential toxicologic properties. Although no harmonized dermal absorption value was available, in vitro studies using human skin samples revealed very low per-cutaneous absorption (0.33% of the applied dose). There are no specific data on the distribution of octocrylene; however, there is some information on background levels of octocrylene and its metabolism, and it has limited presence in plasma and urine from human biomonitoring studies.

Six tentative metabolites of octocrylene have been identified, although metabolite-specific toxicity profiles were not available. Octocrylene generally did not cause eye or skin irritation, skin sensitization, or phototoxicity, but dermal sensitization has been reported in some clinical case studies. Octocrylene is not acutely toxic.

The available data show that octocrylene poses no human health risks when used in sunscreen products at concentrations up to 10%, which is consistent with existing global regulatory safety acceptance and approval of the ingredient.