Label: WL-AAB-Z-W-1117- zinc oxide lotion

  • NDC Code(s): 63931-4463-1
  • Packager: Nanophase Technologies Corporation
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 13, 2021

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  • WL-AAB-Z-W-1117

    GHS label (Bulk)

  • INGREDIENTS AND APPEARANCE
    WL-AAB-Z-W-1117 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4463
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE135.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    MICA (UNII: V8A1AW0880)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-4463-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/24/2021
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(63931-4463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(63931-4463) , manufacture(63931-4463) , pack(63931-4463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amcol Health & Beauty Solutions872684803api manufacture(63931-4463)