Label: WL-AAE-ZT-O-391- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 63931-0391-1
  • Packager: Nanophase Technologies Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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.

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Updated February 15, 2023

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  • WL-AAE-ZT-O-391

    GHS Label

  • INGREDIENTS AND APPEARANCE
    WL-AAE-ZT-O-391 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-0391
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-7 (UNII: 0841698D2F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SQUALANE (UNII: GW89575KF9)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    CETETH-20 (UNII: I835H2IHHX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63931-0391-1150000 mL in 1 DRUM; Type 0: Not a Combination Product10/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/16/2018
    Labeler - Nanophase Technologies Corporation (623502044)
    Registrant - Nanophase Technologies Corporation (623502044)
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