Label: SUNSOVLE MD VOLUMIZE AND RESTORE- zinc oxide lotion

  • NDC Code(s): 84878-823-01, 84878-823-02
  • Packager: Sunsolve MD Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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  • Sunsovle MD Volumize and Restore

    Dosage and Administration

  • Sunsovle MD Volumize and Restore

    Inactive ingredients

  • Sunsovle MD Volumize and Restore

    Indications & usage

  • Sunsovle MD Volumize and Restore

    Active Ingredients

  • Sunsovle MD Volumize and Restore

    keep out of reach of children

  • Sunsovle MD Volumize and Restore

    purpose

  • Sunsovle MD Volumize and Restore

    Warning Label

  • Sunsovle MD Volumize and Restore

    PDP

  • INGREDIENTS AND APPEARANCE
    SUNSOVLE MD VOLUMIZE AND RESTORE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84878-823
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL STEARATE (UNII: C64RTC734W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SQUALANE (UNII: GW89575KF9)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    RUTIN (UNII: 5G06TVY3R7)  
    PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    ETHYL PALMITATE (UNII: IRD3M534ZM)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84878-823-021 in 1 CARTON11/05/2024
    1NDC:84878-823-0150 mL in 1 BOTTLE, DROPPER; 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(84878-823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921manufacture(84878-823) , pack(84878-823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044manufacture(84878-823) , api manufacture(84878-823)