Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use

Dear Acting Deputy Commissioner Zeta, The American Pharmacists Association (APhA) is pleased to submit comments to FDA and the Department of Health and Human Services (HHS) on the "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" notice of availability. If finalized, this proposed order would "amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient."1 APhA represents pharmacists, student pharmacists, and pharmacy technicians in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health. Full comments are attached.