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

  • NDC Code(s): 41442-149-01, 41442-149-02
  • Packager: Omorovicza Kozmetikai Kft.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS PURPOSE
    Titanium Dioxide 2.8% Sunscreen
    Zinc Oxide 7% Sunscreen
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  • USES

    Protects from UVA/B sunrays.

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  • WARNING

    For external use only; do not swallow.

    Stop use if rash or irritation occurs.

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  • DIRECTIONS

    Appy evenly to face and neck.

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  • 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.

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    COMPLEXION CORRECTOR SPF20 
    titanium dioxide and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41442-149
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 28 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 70 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color BROWN Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41442-149-01 1 in 1 BOX
    1 30 mL in 1 BOTTLE, GLASS
    2 NDC:41442-149-02 50 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 01/25/2013
    Labeler - Omorovicza Kozmetikai Kft. (525432105)
    Establishment
    Name Address ID/FEI Business Operations
    Omorovicza Kozmetikai Kft. 525432105 LABEL(41442-149) , MANUFACTURE(41442-149)
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