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
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!