As discussed above, in the November 23, 2015, Federal Register, FDA announced the availability of a draft guidance for industry titled "Over-the-Counter Sunscreens: Safety and Effectiveness Data." This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the SIA is GRASE and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future. Comments are due January 22, 2016.
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