Label: CLE DE PEAU BEAUTE GENTLE PROTECTIVE I- ensulizole, octinoxate, octocrylene, and oxybenzone 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 April 3, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    ENSULIZOLE 1.5%Sunscreen
    OCTINOXATE 4.9%Sunscreen
    OCTOCRYLENE 3.0%Sunscreen
    OXYBENZONE 1.0%Sunscreen
  • Uses

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

  • Directions

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

    WATER, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, ISODODECANE, TRIETHYLHEXANOIN, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, GLYCYL GLYCINE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI (JOB'S TEARS) SEED EXTRACT, SODIUM MAGNESIUM SILICATE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, SODIUM HYDROXIDE, BATYL ALCOHOL, PEG-30 SOY STEROL, DISODIUM EDTA, CELLULOSE GUM, SODIUM METAPHOSPHATE, BUTYLENE GLYCOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

  • Questions?

    1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton

    clé de peau
    BEAUTÉ

    gentle protective emulsion
    SPF 20
    sunscreen

    125mL 4.2 FL. OZ.

    Principal Display Panel - 125 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE GENTLE PROTECTIVE I 
    ensulizole, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-347
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole1.92 g  in 128 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.272 g  in 128 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene3.84 g  in 128 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.28 g  in 128 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIGLYCINE (UNII: 10525P22U0)  
    SERINE (UNII: 452VLY9402)  
    GINKGO (UNII: 19FUJ2C58T)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-347-101 in 1 CARTON
    1128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2011
    Labeler - SHISEIDO CO., LTD. (690536453)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO CO., LTD.695087684MANUFACTURE(52685-347) , ANALYSIS(52685-347)