Label: CLE DE PEAU BEAUTE UV PROTECTION- octinoxate, octocrylene, oxybenzone and zinc oxide cream

  • 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 02/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    OCTINOXATE 7.4% Sunscreen
    OCTOCRYLENE 3.0% Sunscreen
    OXYBENZONE 1.5% Sunscreen
    ZINC OXIDE 9.0% Sunscreen
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  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
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  • Warnings

    For external use only

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • apply evenly before sun exposure and as needed.
    • children under 6 months of age: ask a doctor.
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  • Inactive Ingredients

    WATER • BUTYLENE GLYCOL • ISOHEXADECANE • DIMETHICONE • ISOPROPYL MYRISTATE • GLYCERIN • POLYMETHYLSILSESQUIOXANE • SD ALCOHOL 40-B • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • PEG-6 • XYLITOL • PEG-32 • SODIUM HYALURONATE • TOCOPHERYL ACETATE • LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE • CRATAEGUS MONOGYNA FLOWER EXTRACT • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • 2-O-ETHYL ASCORBIC ACID • SODIUM ACETYLATED HYALURONATE • POLYQUATERNIUM-51 • SAXIFRAGA SARMENTOSA EXTRACT • UNCARIA GAMBIR EXTRACT • GINKGO BILOBA LEAF EXTRACT • THYMUS SERPILLUM EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • CURCUMA LONGA (TURMERIC) ROOT EXTRACT • HYPERICUM ERECTUM EXTRACT • HYDROLYZED SILK • BUPLEURUM FALCATUM ROOT EXTRACT • HYDROGENATED POLYDECENE • SILICA • ISOSTEARIC ACID • HYDROGEN DIMETHICONE • TRISODIUM EDTA • BHT • ALCOHOL • TOCOPHEROL • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE • MICA •

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  • Questions?

    1-800-906-7503

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  • PRINCIPAL DISPLAY PANEL - 50 mL Carton

    clé de peau

    BEAUTÉ

    SPF
    50
    PA+++
    sunscreen

    UV protection cream

    50mL NET WT. 1.9 OZ.

    Principal Display Panel - 50 mL Carton
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  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE UV PROTECTION 
    octinoxate, octocrylene, oxybenzone, and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-259
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 4.06 g  in 54.91 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 1.65 g  in 54.91 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.82 g  in 54.91 g
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide 4.94 g  in 54.91 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
    THIOTAURINE (UNII: NQZ2D7AO62)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
    GINKGO (UNII: 19FUJ2C58T)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    TURMERIC (UNII: 856YO1Z64F)  
    BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52686-259-60 1 in 1 CARTON
    1 54.91 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 03/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    Name Address ID/FEI Business Operations
    SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-259) , ANALYSIS(52686-259)
    Establishment
    Name Address ID/FEI Business Operations
    Davlyn Industries Inc 624436254 MANUFACTURE(52686-259)
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