Sunscreen Innovation Act

L. 113–195 (text) (PDF)) is a 2014 law that amended the Federal Food, Drug, and Cosmetic Act to establish an expedited process for the review and approval of over-the-counter (OTC) sunscreens.

[2] The new law gave the FDA one year to respond to the existing backlog of sunscreen ingredient approval requests, and then 18 months to reply to any future applications.

[3] The bill was introduced during the 113th United States Congress by Rep. Ed Whitfield (R, KY-1) and Sen. Jack Reed (D, RI), and signed into law by President Barack Obama on November 26, 2014.

[1] The bill would make sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act.

[1] The bill would establish a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients.

4250 would modify the review process that allows the marketing of certain new ingredients in non-prescription sunscreen based on a determination by the Food and Drug Administration (FDA) that they are generally recognized as safe and effective.

[11] The bill would impose private-sector mandates, as defined in UMRA, because it would allow FDA to require that marketing applications for certain sunscreen products be submitted in a new standardized format.