News – SIA Empowers FDA to Review OTC Sunscreen Active Ingredients

Theresa M. Michele, M.D., Director of the Division of Nonprescription Drug Products in FDA’s Center for Drug Evaluation and Research’s Office of New Drugs posted an article Feb 24 on FDAVoice to indicate that any non-prescription sunscreen active ingredients used in over-the-counter (OTC) drugs, particularly used in one or more foreign countries, need to be evaluated and approved by the Food and Drug Administration before they can be used in products intended for the U.S. market.

The Sunscreen Innovation Act (SIA), passed by Congress on Nov. 26, 2014, provides the FDA the authority to review the safety and effectiveness of nonprescription sunscreen active ingredients. Before SIA was enacted, the FDA followed a procedure known as the Time and Extent Applications process or TEA process to review sunscreen active ingredients. The new law allows sponsors to request the FDA to evaluate active ingredients that have been used in OTC drug products, particularly those marketed in other countries.

The TEA process consists of two steps. First, the FDA needs to determine the eligibility of an ingredient of concern and then determine its GRASE status (Generally recognized as safe and effective) when it is intended for use in an OTC drug product. If the ingredient is GRASE, then it can be used in sunscreen products intended for the U.S. market. And if it is not, then the FDA will ask for more data from the sponsors to evaluate the safety and effectiveness of the ingredient.

The FDA was asked to evaluate eight ingredients before SIA was enacted, and the agency has now reviewed the data and found none eligible for the GRASE status. That is, the FDA needs more data to determine the safety and effectiveness of these sunscreen ingredients. (by staff at

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