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FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection

 
• By Malcolm Spicer

FDA advises BASF that the information the firm submitted is not sufficient to establish octyl triazone as GRASE. The agency’s third rejection this year of a sunscreen TEA could concern advocates on Capitol Hill and in the industry for using the process for adding ingredients to the OTC sunscreen monograph.

BASF AG’s time and extent application does not support adding octyl triazone to the OTC sunscreen monograph, FDA says in its third finding this year that a TEA for sunscreen ingredients is inadequate.

FDA’s decisions on the three TEAs could concern advocates on Capitol Hill and in the industry who want to use the TEA process to expand the OTC sunscreen monograph. However,...

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