Label: WL-AAB-Z-W-1001- zinc oxide lotion

  • NDC Code(s): 63931-4438-1
  • 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 September 10, 2021

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  • WL-AAB-Z-W-1001 GHS Label

    GHS label (Bulk)

  • INGREDIENTS AND APPEARANCE
    WL-AAB-Z-W-1001 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4438
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    MICA (UNII: V8A1AW0880)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ZEIN (UNII: 80N308T1NN)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-4438-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/06/2021
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(63931-4438)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(63931-4438) , manufacture(63931-4438) , pack(63931-4438)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amcol Health & Beauty Solutions872684803api manufacture(63931-4438)