Label: SUNSOLVE MD FIRM AND REPLENISH- zinc oxide lotion

  • NDC Code(s): 84878-199-01, 84878-199-02, 84878-199-03, 84878-199-04
  • Packager: Sunsolve MD Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2024

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  • Sunsolve MD Firm and Replenish

    Dosage and Administration

  • Sunsolve MD Firm and Replenish

    Inactive ingredients

  • Sunsolve MD Firm and Replenish

    Indications & usage

  • Sunsolve MD Firm and Replenish

    Active Ingredients

  • Sunsolve MD Firm and Replenish

    keep out of reach of children

  • Sunsolve MD Firm and Replenish

    purpose

  • Sunsolve MD Firm and Replenish

    Warning Label

  • Sunsolve MD Firm and ReplenishSunsolve MD Firm and Replenish

    PDP

  • INGREDIENTS AND APPEARANCE
    SUNSOLVE MD FIRM AND REPLENISH 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84878-199
    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
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM HYALURONATE (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CERAMIDE NP (UNII: 4370DF050B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    NYLON-12 (UNII: 446U8J075B)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84878-199-021 in 1 CARTON11/06/2024
    1NDC:84878-199-0148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:84878-199-041 in 1 CARTON11/06/2024
    2NDC:84878-199-0313 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 DrugM02011/06/2024
    Labeler - Sunsolve MD Inc (119376976)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(84878-199)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921pack(84878-199) , manufacture(84878-199)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(84878-199) , manufacture(84878-199)
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