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This refers to an aerosol spray sunscreen formulation containing a combination of chemical UV filters, including avobenzone, oxybenzone, ecamsule, octocrylene, homosalate, octisalate, and octinoxate. It was evaluated by the U.S. Food and Drug Administration (FDA) in a Phase 1 maximal usage trial (MUsT), specifically NCT03582215, to investigate the systemic absorption and pharmacokinetics of these active ingredients when applied under conditions of high-volume topical use. These ingredients function as sunscreen agents by absorbing ultraviolet (UV) radiation, thereby protecting the skin from sunburn and long-term damage such as photoaging and skin cancer. The study aimed to determine if plasma concentrations of these filters exceed the FDA's safety threshold of 0.5 ng/mL, which would trigger further nonclinical safety assessments.
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