WL-AAJ-Z-W-508 (KOPARI 50ML) (ZINC OXIDE) LOTION [NANOPHASE TECHNOLOGIES CORPORATION]

WL-AAJ-Z-W-508 (KOPARI 50ML) (ZINC OXIDE) LOTION [NANOPHASE TECHNOLOGIES CORPORATION]
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NDC 63931-4312-1
Set ID 826a1017-f8b2-cc0b-e053-2a91aa0a9553
Category HUMAN OTC DRUG LABEL
Packager Nanophase Technologies Corporation
Generic Name
Product Class
Product Number
Application Number PART352
  • WL-AAJ-Z-W-508 (Kopari) GHS Label

    Label-GHS

  • INGREDIENTS AND APPEARANCE
    WL-AAJ-Z-W-508 (KOPARI 50ML) 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-4312-1328600 mL in 1 DRUM; Type 0: Not a Combination Product02/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2019
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Cirporation (623502044)

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