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BASF Ingredient Suffers Identity Crisis In FDA Review

This article was originally published in The Tan Sheet

Executive Summary

FDA says BASF must clarify whether tests studied bisoctrizole or the firm’s compound marketed as Tinosorb M, which combines bisoctrizole and other ingredients.

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BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts

The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.

BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts

The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.

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Under the Sunscreen Innovation Act, FDA’s tentative determinations on sunscreen ingredients TEAs are deemed proposed orders and must be made available for comment. The agency seeks input on six insufficient-data letters issued to sunscreen TEA sponsors in 2014.

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