Label: SUNKISS- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 6, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    Titanium Dioxide 1.35%Sunscreen
    Zinc Oxide 6%Sunscreen
  • USES

    Protects from UVA/B sunrays.

  • WARNING

    For external use only; do not swallow.

    Stop use if rash or irritation occurs.

  • DIRECTIONS

    Appy evenly to face and neck.

  • INGREDIENTS

    Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Titanium Dioxide, Corundum (Pro Ruby Crystal), Cetearyl Ethylhexanoate, Cetearyl Olivate, Sorbitan Olivate, Stearyl Heptanoate, Cetearyl Alcohol, Saccharomyces Ferment Extract, Phenoxyethanol, Polyhydroxystearic Acid, Isostearic Acid, Mica, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Prunus Armeniaca (Apricot) Kernel Oil, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Malpighia Punicifolia (Acerola) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pectin, Phospholipids, Tocopherol, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Lactic Acid, Galactoarabinan, Isopropyl Titanium Triisostearate, CI 77492/ CI 77491/ CI 77499 (Iron Oxides).

  • SPL UNCLASSIFIED SECTION

    Product of Hungary
    www.omorovicza.com
    Omorovicza Kft, 2 Andrassy Ut, 1061 Budapest

  • PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton

    SUNKISS
    SPF 15
    NAPVARÁZS

    Omorovicza
    BUDAPEST

    e 1.7 fl oz    50ml

    Principal Display Panel - 50ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SUNKISS   SPF15
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide0.675 mL  in 50 mL
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide3 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    glycerin (UNII: PDC6A3C0OX)  
    squalane (UNII: GW89575KF9)  
    aluminum oxide (UNII: LMI26O6933)  
    sorbitan olivate (UNII: MDL271E3GR)  
    STEARYL ETHYLHEXANOATE (UNII: X8707A2274)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    isostearic acid (UNII: X33R8U0062)  
    mica (UNII: V8A1AW0880)  
    geraniol (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    linalool, dl- (UNII: D81QY6I88E)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    acerola (UNII: XDD2WEC9L5)  
    apple (UNII: B423VGH5S9)  
    pectin (UNII: 89NA02M4RX)  
    alpha-tocopherol (UNII: H4N855PNZ1)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    xanthan gum (UNII: TTV12P4NEE)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    lactic acid (UNII: 33X04XA5AT)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41442-133-011 in 1 BOX
    150 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/06/2011
    Labeler - Omorovicza Kozmetikai Kft (525432105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omorovicza Kozmetikai Kft525432105LABEL, MANUFACTURE
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