Label: WL-AAJ-Z-W-914- zinc oxide lotion

  • NDC Code(s): 63931-4421-1
  • 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 March 15, 2021

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  • WL-AAJ-Z-W-914

    GHS Label

  • INGREDIENTS AND APPEARANCE
    WL-AAJ-Z-W-914 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4421
    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
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SQUALANE (UNII: GW89575KF9)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYESTER-7 (UNII: 0841698D2F)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-4421-1160000000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2021
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Cirporation (623502044)
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