Label: SUNSOLVE MD MINERAL SHADE AMBER 002- zinc oxide lotion

  • NDC Code(s): 84878-402-01, 84878-402-02
  • Packager: Sunsolve MD Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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  • Sunsolve MD Mineral Shade Amber 002

    Dosage and Administration

  • Sunsolve MD Mineral Shade Amber 002

    Inactive ingredients

  • Sunsolve MD Mineral Shade Amber 002

    Indications & usage

  • Sunsolve MD Mineral Shade Amber 002

    Active Ingredients

  • Sunsolve MD Mineral Shade Amber 002

    keep out of reach of children

  • Sunsolve MD Mineral Shade Amber 002

    purpose

  • Sunsolve MD Mineral Shade Amber 002

    Warning Label

  • Sunsolve MD Mineral Shade Amber 002

    PDP

  • INGREDIENTS AND APPEARANCE
    SUNSOLVE MD MINERAL SHADE AMBER 002 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84878-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ISODODECANE (UNII: A8289P68Y2)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-10 (UNII: 761NX2Q08Y)  
    CAPRYLYL METHICONE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84878-402-021 in 1 CARTON11/05/2024
    1NDC:84878-402-0128 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/05/2024
    Labeler - Sunsolve MD Inc (119376976)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(84878-402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921pack(84878-402) , manufacture(84878-402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(84878-402) , manufacture(84878-402)
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