Label: WL-AAB-Z-W-1158- zinc oxide lotion

  • NDC Code(s): 63931-1158-1
  • 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 May 22, 2023

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  • WL-AAB-Z-W-1158

    GHS

  • INGREDIENTS AND APPEARANCE
    WL-AAB-Z-W-1158 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-1158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE154 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN, (+)- (UNII: XDK458E1J9)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-1158-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/22/2023
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(63931-1158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(63931-1158) , manufacture(63931-1158)
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