Label: SUNSCREEN- zinc oxide lip balm stick
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Contains inactivated NDC Code(s)
NDC Code(s): 62932-267-38 - 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 May 5, 2022
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- Official Label (Printer Friendly)
- Active Ingredient Section
- INACTIVE INGREDIENT
- Indications and Usage
- Keep out of reach of children
- Purpose Section
- Warnings Section
- Label Artwork
- Unit Carton Artwork
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INGREDIENTS AND APPEARANCE
SUNSCREEN
zinc oxide lip balm stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62932-267 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10.5 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SHEA BUTTER (UNII: K49155WL9Y) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F) WHITE WAX (UNII: 7G1J5DA97F) SUNFLOWER OIL (UNII: 3W1JG795YI) RASPBERRY SEED OIL (UNII: 9S8867952A) .DELTA.-TOCOPHEROL (UNII: JU84X1II0N) TAMANU OIL (UNII: JT3LVK84A1) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) JOJOBA OIL (UNII: 724GKU717M) .BETA.-TOCOPHEROL (UNII: 9U6A490501) COCONUT OIL (UNII: Q9L0O73W7L) Product Characteristics Color white Score Shape Size Flavor PINEAPPLE (Pina Colada) , COCONUT (Pina Colada) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62932-267-38 1 in 1 CARTON 05/05/2022 1 4.2 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/05/2022 Labeler - Private Label Select Ltd CO (005415463)