FDA MUsT Shows Sunscreen Ingredient Absorption ‘Not Just A Theoretical Concern’
In FDA’s maximal usage trial published May 6 in JAMA, oxybenzone, octocrylene, avobenzone and ecamsule all absorbed into subjects’ bloodstreams at levels that raise systemic safety questions. The active ingredients are among 12 that FDA identified in a February proposed rule as currently lacking data to support continued GRASE status.
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The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
The iconic sunscreen brand aims to capitalize on growing demand for mineral sunscreens – widely perceived as consumers’ safest option in sun defense – by positioning offerings that contain mixes of mineral and chemical UV filters as “mineral-based,” according to a suit filed in December in California federal court.
Personal Care Product Council submits work plan to FDA setting 2023 date for completing MUsT trial on one of eight UV filters, with additional trials to follow. Research firm considers the estimate consistent with the industry's experience with the trials, but says it could design and conduct the required pilot and pivotal studies in six months.