Label: COMPLEXION CORRECTOR SPF20- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 25, 2013

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    Titanium Dioxide 2.8%Sunscreen
    Zinc Oxide 7%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, Glycerin, Squalane, Stearyl Heptanoate, Cetearyl Olivate, Octyldodecanol, Corundum (Pro Ruby Crystal), Cetearyl Ethylhexanoate, Sorbitan Olivate, Alcohol Denat., Cetearyl Alcohol, Phenoxyethanol, Mica, Isononyl Isononanoate, Isostearic Acid, Ascorbyl Tetraisopalmitate, Niacinamide, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Polyhydroxystearic Acid, Isopropyl Myristate, Zinc PCA, Disodium EDTA, Pyrus Malus (Apple) Fruit Extract, Geraniol, Sodium Hyaluronate, Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Ethylhexylglycerin, Lactic Acid, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Citronellol, Parfum (Fragrance), Isopropyl Titanium Triisostearate, Nasturtium Officinale Flower/Leaf Extract, Xanthan Gum, Stearalkonium Hectorite, Pectin, Phospholipids, Linalool, Propylene Carbonate.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Pump Bottle Carton

    COMPLEXION CORRECTOR

    SPF 20

    Omorovicza

    BUDAPEST

    e 1.0 fl oz 30ml

    Principal Display Panel - 30 ml Pump Bottle Carton
  • INGREDIENTS AND APPEARANCE
    COMPLEXION CORRECTOR SPF20 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide28 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)  
    Glycerin (UNII: PDC6A3C0OX)  
    Squalane (UNII: GW89575KF9)  
    Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Mica (UNII: V8A1AW0880)  
    Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Niacinamide (UNII: 25X51I8RD4)  
    Apple (UNII: B423VGH5S9)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Zinc Pidolate (UNII: C32PQ86DH4)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Geraniol (UNII: L837108USY)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Apricot Kernel Oil (UNII: 54JB35T06A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    .Beta.-Citronellol, (+/-)- (UNII: 565OK72VNF)  
    Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Pectin (UNII: 89NA02M4RX)  
    Linalool, (+)- (UNII: F4VNO44C09)  
    Nasturtium Officinale Flowering Top (UNII: W1N2U8I64G)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41442-149-011 in 1 BOX
    130 mL in 1 BOTTLE, GLASS
    2NDC:41442-149-0250 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/25/2013
    Labeler - Omorovicza Kozmetikai Kft. (525432105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omorovicza Kozmetikai Kft.525432105LABEL(41442-149) , MANUFACTURE(41442-149)