Why Evaluate the Sunscreen Active Oxybenzone (Benzophenone-3) for Carcinogenicity and Reproductive Toxicology or Consider it Unsafe for Human Use?

Abstract

On February 26, 2019, the Food & Drug Administration (FDA) published an update to the Sunscreen Drug Products for Overthe-Counter Human Use in the Federal Register [1], requesting additional information on 12 petroleum-based sunscreen actives (cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone). This is because the public record does not currently contain sufficient data to support that these drugs are Generally Recognized as Safe and Effective (GRASE). The FDA went on to conduct and publish a small clinical trail [2] to determine whether four of these drugs (avobenzone, oxybenzone, octocrylene, and ecamsule) absorb into the systemic circulation and whether they would exceed the FDA level for toxicological concern (0.5 ng/mL). The data collected demonstrated that all four sunscreen drugs absorbed through the skin and into the blood, and accumulated above the 0.5 ng/mL level within the first day (4 applications) of the study. Oxybenzone exceeded the level of concern after the first application demonstrating an overall maximum plasma concentration between 169.3 and 209.6 ng/mL for concentrations ranging from 4% to 6% in products, respectively.