U.S. Food and Drug Administration Confidential Protocol No. SCR-005 CLINICAL STUDY PROTOCOL Assessment of the Human Systemic Absorption of Sunscreen Ingredients PROTOCOL NO. SCR-005 Sponsor: U.S. Food and Drug Administration White Oak Building #64, Room 2072 10903 New Hampshire Avenue Silver Spring, MD 20993 Sponsor Study Lead David Strauss, MD, PhD and Medical Monitor: Director, Division of Applied Regulatory Science U.S. Food and Drug Administration Telephone: 301-796-6323 Email:
[email protected] Project Managers: Murali Matta, PhD U.S. Food and Drug Administration Telephone: 240-402-5325 Email:
[email protected] Robbert Zusterzeel, MD, PhD, MPH U.S. Food and Drug Administration Telephone: 301-796-3750 Email:
[email protected] Study Monitor: Jill Brown RIHSC Project Manager U.S. Food and Drug Administration Version of Protocol: 1.4 Date of Protocol: 13 December 2018 CONFIDENTIAL The concepts and information contained in this document or generated during the study are considered proprietary and may not be disclosed in whole or in part without the expressed written consent of U.S. Food and Drug Administration. 13 December 2018 Page 1 of 54 Version 1.4 U.S. Food and Drug Administration Confidential Protocol No. SCR-005 Sponsor Signature Page This study will be conducted with the highest respect for the individual participants in accordance with the requirements of this clinical study protocol and also in accordance with the following: The ethical principles that have their origin in the Declaration of Helsinki; International Council for Harmonisation (ICH) harmonised tripartite guideline E6 (R1): Good Clinical Practice; and All applicable laws and regulations, including without limitation, data privacy laws and compliance with appropriate regulations, including human subject research requirements.