FDA Denies Remaining Sunscreen TEAs, Offers Primer On Why They Fail

In proposed orders to be published Feb. 25, FDA rejects L'Oreal USA’s time and extent application for ecamsule and Merck & Co.’s TEA for enzacamene. Division of Nonprescription Clinical Evaluation Director Theresa Michele acknowledges the decisions “may be disappointing to some.”

FDA has denied the final two pending OTC sunscreen ingredient applications and offered perspective on why it is not approving the proposals after Congress passed 2014 legislation to facilitate making more of the ingredients available.

In separate proposed orders to be published in the Feb. 25 Federal Register, FDA rejected [L'Oreal USA Inc.]’s time and...

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