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FDA Sunscreen MUsT’s ‘Real World’ Applicability Under Debate, Which Could Hold Up Testing

Executive Summary

Spaulding Clinical, which the FDA contracted for its sunscreen maximal usage trial published in May, is in discussions with a handful of sunscreen industry players about doing more MUsTs to fulfill data needs identified by the agency. Meanwhile, leading trade groups are interested in talking to the FDA about developing sunscreen study protocols that more accurately reflect real-world consumer usage.

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