Label: SUN PREMIUM FACE 50 SPF - oxybenzone, octinoxate, avobenzone and titanium dioxide cream 

  • NDC Code(s): 75870-006-01, 75870-006-02
  • Packager: LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
  • 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 06/11

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  • PRINCIPAL DISPLAY PANEL

    ATACHE

    SCIENTIFIC COSMETIC

    SUN PREMIUM


    FACE
    50+ SPF
    UVA-UVB

    VERY
    HIGH

    COLOR

    ANTIAGE PROTECTIVE FACE CREAM
    WITH COLOR

    75 ml e  2.53 FL OZ
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  • DESCRIPTION

    ANTIAGE PROTECTIVE FACE CREAM

    WITH COLOR


    Innovative combination of a selection of extracts that offer a perfect balance between sun protection and beauty.  A soft, pleasant texture on your skin, that lets you enjoy an even tan while it protects your face from the signs of ageing and gives a firmer appearance.
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  • INSTRUCTIONS FOR USE

    INSTRUCTIONS FOR USE:  Apply evenly to the face and neck half an hour before sunbathing.  Apply again each 1-2 hours or after bathing.

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  • WARNINGS

    WARNINGS:   For external use only.  Keep out of reach of children.  Avoid contact with eyes.  Discontinue use if signs of irritation of rash appear.

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    OXYBENZONE 5% - sunscreen

    OCTINOXATE 5% - sunscreen

    AVOBENZONE 2% - sunscreen

    TITANIUM DIOXIDE 1.5% - sunscreen



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  • INACTIVE INGREDIENT

    OTHER INGREDIENTS:   AQUA (WATER), ALOE VERA GEL, UREA, CETEARYL ALCOHOL, GLLYCERIN, C12-20 ALKYL BENZOATE, ISOHEXADECANE, TRIETHYLEXANOIN, CETYL PALMITATE, DIMETHICONE, TRIMETHOXYCAPRYLYLSILANE, STEARETH-2, BUTYROSPERMUM PARK II (SHEA BUTTER), PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, CYCLOMETHICONE, DIMETHICONOL, CETETH-25, PEG-0 STEARATE, BEHENYL ALCOHOL, SODIUM PCA, GLYCERETH-26, STEARETH-21, SQUALANE, PARAFFIN, DIAZOLIDINYL UREA, ECHINACEA ANTUSTIFOLIA EXTRACT, CENTELLA ASIATICA EXTRACT, FUCUS VESICULOSUS EXTRACT, TRIGONELLA FOENUM-GRAECUM SEED EXTRACT, PROPYLENE GLYCOL, PEG-20 CASTOR OIL, ALCOHOL DENAT, PEG-60 HYDROGENATED CASTOR OIL, CALCIUM PANTOTHENATE, INOSITOL, BIOTIN, RETINOL, TOCOPHERYL ACETATE, GLYCERYL LINOLEATE, GLYCERYL LINOLENATE, GLYCERYL ARACHIDONATE, ALUMINIUM STEARATE, ALUMINA, XANTHAN GUM, ALLANTOIN, COCOS NUCIFERA (COCONUM OIL), GARDENIA TAHITENSIS (TIARE FLOWER), PARFUM (FRAGRANCE), LIMONENE, LINALOOL, TETRASODIUM EDTA, POLYHYDROXYESTEARIC ACID, TOCOPHERYL ACETATE, DIPALMITOYL HYDROXYPROLINE.


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  • PRINCIPAL DISPLAY PANEL

    Image of CartonEnter section text here

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  • INGREDIENTS AND APPEARANCE
    SUN PREMIUM FACE 50 SPF 
    oxybenzone, octinoxate, avobenzone, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:75870-006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYBENZONE (OXYBENZONE) OXYBENZONE 3.75 mL  in 75 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 3.75 mL  in 75 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 1.5 mL  in 75 mL
    TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 1.185 mL  in 75 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALOE VERA LEAF  
    UREA  
    CETOSTEARYL ALCOHOL  
    GLYCERIN  
    C12-20 ALKYL BENZOATE  
    ISOHEXADECANE  
    TRIETHYLHEXANOIN  
    CETYL PALMITATE  
    DIMETHICONE  
    TRIMETHOXYCAPRYLYLSILANE  
    STEARETH-2  
    SHEA BUTTER  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    CYCLOMETHICONE  
    CETETH-25  
    PEG-9 STEARATE  
    DOCOSANOL  
    SODIUM PYRROLIDONE CARBOXYLATE  
    GLYCERETH-26  
    STEARETH-21  
    SQUALANE  
    PARAFFIN  
    DIAZOLIDINYL UREA  
    ECHINACEA ANGUSTIFOLIA  
    CENTELLA ASIATICA  
    FUCUS VESICULOSUS  
    FENUGREEK SEED  
    PROPYLENE GLYCOL  
    CASTOR OIL  
    ALCOHOL  
    POLYOXYL 60 HYDROGENATED CASTOR OIL  
    CALCIUM PANTOTHENATE  
    INOSITOL  
    BIOTIN  
    RETINOL  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    GLYCERYL LINOLEATE  
    GLYCERYL LINOLENATE  
    GLYCERYL ARACHIDONATE  
    ALUMINUM STEARATE  
    ALUMINUM OXIDE  
    XANTHAN GUM  
    ALLANTOIN  
    COCONUT OIL  
    GARDENIA TAITENSIS FLOWER  
    LIMONENE, (+)-  
    LINALOOL, DL-  
    EDETATE SODIUM  
    HYDROXYSTEARIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    DIPALMITOYL HYDROXYPROLINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75870-006-02 1 in 1 CARTON
    1 NDC:75870-006-01 75 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/15/2007
    Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193)
    Establishment
    Name Address ID/FEI Business Operations
    LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA 467582193 manufacture
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