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Sunscreen meetings

Sunscreen meetings

October 12, 2017: On behalf of BASF Corp ("BASF"), Morgan, Lewis & Bockius LLP requests a non-public meeting with the appropriate Center for Drug Evaluation and Research I OTC staff to discuss BASF's pending Time and Extent Applications (TEAs) In response to FDA's Proposed Sunscreen Orders dated September 13, 2014· and N0Vember 13, 2014 for Bisoctrizole and Bemotrizinol respectively.

September 13, 2016: A meeting to discuss the protocols submitted by Ichthyol Gesellschaft for FDA Docket No. FDA-2009-N-0146 regarding the FDA Refusal-to-File letter issued for sodium shale oil sulfate on April 20, 2016.

September 7, 2016: A meeting to discuss sunscreen formulations with the Personal Care Products Council.

May 11, 2015: A meeting to discuss the proposed order issued to L’Oréal USA on February 25, 2015 pertaining to the safety and efficacy submission on Ecamsule as authorized under the Time and Extent Application procedures in 21 CFR 330.14.

March 20, 2015: Meeting to discuss the proposed order pertaining to FDA’s review of the safety and efficacy data to support the GRASE status of the sunscreen filter Bisoctrizole.

March 19, 2015: Meeting to discuss the proposed orders pertaining to FDA’s review of the safety and efficacy data to support the GRASE status of the sunscreen filters Octyl Triazone and Bemotrizinol.

March 18, 2015: Discuss the proposed order issued to L’Oréal USA on August 29, 2014 pertaining to the safety and efficacy submission on drometrizole trisiloxane in sunscreens as authorized under the Time and Extent Application procedures in 21 CFR 330.14.

February 4, 2015: FDA meeting with stakeholders to discuss plans for implementation of the SIA.

 

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