Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period

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The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over- the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.