Label: SUNSOLVE MD CALM AND REVITALIZE- zinc oxide lotion

  • NDC Code(s): 84878-654-01, 84878-654-02
  • Packager: Sunsolve MD Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2024

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  • Sunsolve MD Calm and Revitalize

    Dosage and Administration

  • Sunsolve MD Calm and Revitalize

    Inactive ingredients

  • Sunsolve MD Calm and Revitalize

    Indications & usage

  • Sunsolve MD Calm and Revitalize

    Active Ingredients

  • Sunsolve MD Calm and Revitalize

    keep out of reach of children

  • Sunsolve MD Calm and Revitalize

    purpose

  • Sunsolve MD Calm and Revitalize

    Warning Label

  • Sunsolve MD Calm and Revitalize

    PDP

  • INGREDIENTS AND APPEARANCE
    SUNSOLVE MD CALM AND REVITALIZE 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84878-654
    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
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETETH-20 (UNII: I835H2IHHX)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SQUALANE (UNII: GW89575KF9)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    SCLEROTIUM GUM (UNII: 2X51AD1X3T)  
    AVENA SATIVA (OAT) KERNEL EXTRACT (UNII: Z6J799EAJK)  
    ALOE BARBADENSIS LEAF JUICE POWDER (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PYRUS MALUS (APPLE) FRUIT (UNII: B423VGH5S9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84878-654-021 in 1 CARTON11/08/2024
    1NDC:84878-654-0148 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 DrugM02011/08/2024
    Labeler - Sunsolve MD Inc (119376976)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921manufacture(84878-654) , pack(84878-654)
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