Label: WL-AAJ-Z-W-508 (KOPARI 50ML)- zinc oxide lotion
- NDC Code(s): 63931-4312-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 21, 2019
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INGREDIENTS AND APPEARANCE
WL-AAJ-Z-W-508 (KOPARI 50ML)
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCOS NUCIFERA WHOLE (UNII: 245J88W96L) PHENYLPROPANOL (UNII: 0F897O3O4M) PROPANEDIOL (UNII: 5965N8W85T) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) TOCOPHEROL (UNII: R0ZB2556P8) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) WATER (UNII: 059QF0KO0R) .ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) UBIQUINONE Q2 (UNII: I7T5V2W47R) ALLANTOIN (UNII: 344S277G0Z) SALICYLIC ACID (UNII: O414PZ4LPZ) TRIBEHENIN (UNII: 8OC9U7TQZ0) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CITRULLUS LANATUS VAR. CITROIDES WHOLE (UNII: N1HQX01Z1T) COCO-CAPRYLATE (UNII: 4828G836N6) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ISODECYL SALICYLATE (UNII: S7097PFP4C) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) POLYESTER-7 (UNII: 0841698D2F) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4312-1 328600 mL in 1 DRUM; Type 0: Not a Combination Product 02/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/08/2019 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Cirporation (623502044)
