FDA To Try Its Hand At Sunscreen Absorption Study, A MUsT For TEA Sponsors

16 Mar 2018

Agency may be teaming with an outside party to conduct a maximal usage trial on sunscreen formulations. FDA guidance advises MUsTs to assess systemic exposure to sunscreen drug ingredients, but ingredient sponsors have been loath to invest in such tests due to questions about cost and viability.

FDA is in the process of contracting a study to assess systemic exposure to sunscreen formulations, an undertaking that could serve public health interests and those of sunscreen ingredient firms seeking agency approval of their formulations as generally recognized as safe and effective.

"Most sunscreen active ingredients are organic chemicals and some have been shown to be absorbed through human skin with detectable...