Label: SUNSCREEN- zinc oxide sunscreen ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 62932-218-26 - Packager: Private Label Select Ltd CO
- 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 July 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- Indications and Usage
- Keep out of reach of children
- OTC-Purpose Section
- OTC-Active Ingredient Section
- Front Label
- Back Label
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
zinc oxide sunscreen ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-218 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength .BETA.-TOCOPHEROL (UNII: 9U6A490501) CASTOR OIL (UNII: D5340Y2I9G) FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SUNFLOWER OIL (UNII: 3W1JG795YI) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F) MICA (UNII: V8A1AW0880) CARNAUBA WAX (UNII: R12CBM0EIZ) SHEA BUTTER (UNII: K49155WL9Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) .DELTA.-TOCOPHEROL (UNII: JU84X1II0N) COCOA BUTTER (UNII: 512OYT1CRR) WHITE WAX (UNII: 7G1J5DA97F) CANDELILLA WAX (UNII: WL0328HX19) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62932-218-26 46 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2020 Labeler - Private Label Select Ltd CO (005415463) Registrant - Private Label Select Ltd CO (005415463)
