Label: SPF 50 MINERAL POWDER SUNSCREEN- titanium dioxide, zinc oxide powder
- NDC Code(s): 83369-001-01
- Packager: Smalls Brand LLC DBA Roe Wellness
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 19, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 50 MINERAL POWDER SUNSCREEN
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83369-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.9 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.1 g in 100 g Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ASCORBIC ACID (UNII: PQ6CK8PD0R) CERAMIDE 1 (UNII: 5THT33P7X7) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) FERRIC OXIDE RED (UNII: 1K09F3G675) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83369-001-01 6 g in 1 CARTON; Type 0: Not a Combination Product 04/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/13/2023 Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)