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FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection

This article was originally published in The Rose Sheet

Executive Summary

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 time-and-extent application could raise concerns among lawmakers and industry members amid a push to move sunscreen ingredients through the TEA process so consumers have access to updated options for sun protection.

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FDA Seeks Comment On Proposed Orders Under Sunscreen Innovation Act

Under the Sunscreen Innovation Act enacted in late 2014, FDA’s tentative determinations on time and extent applications for sunscreen ingredients are now deemed proposed orders and must be made available for public comment. The agency seeks input on six insufficient-data letters issued to sunscreen TEA sponsors in 2014, including its latest to BASF regarding bemotrizinol, marketed as Tinosorb S.

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