Label: CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER- ensulizole and octinoxate 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

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    ENSULIZOLE 2.0%Sunscreen
    OCTINOXATE 4.9%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 generously before sun exposure and as needed.
    • apply and reapply as directed to avoid lowering protection.
    • apply to all skin exposed to the sun.
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    WATER, GLYCERIN, BUTYLENE GLYCOL, CYCLOMETHICONE, DIPROPYLENE GLYCOL, SILICA, DIMETHICONE, TRIETHYLHEXANOIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, BEHENETH-20, TRIETHANOLAMINE, METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl, XANTHAN GUM, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, LAURYL BETAINE, BUPLEURUM FALCATUM ROOT EXTRACT, UNCARIA GAMBIR EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, SODIUM METAPHOSPHATE, CELLULOSE GUM, TRISODIUM EDTA, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, SODIUM BENZOATE, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

  • Questions?

    1-800-906-7503

  • SPL UNCLASSIFIED SECTION

    Distributed by
    SHISEIDO COSMETICS (AMERICA) LTD.
    NEW YORK, NY 10022

  • PRINCIPAL DISPLAY PANEL - 20mL Bottle Carton

    SYNACTIF

    Daytime moisturizer
    SPF 17 sunscreen

    20mL NET WT. .75 OZ.

    PRINCIPAL DISPLAY PANEL - 20mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER 
    ensulizole and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole430 mg  in 21.52 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate1054 mg  in 21.52 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-380-101 in 1 CARTON
    121.52 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/01/2009
    Labeler - SHISEIDO CO., LTD. (690536453)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO CO., LTD.695087684MANUFACTURE(52685-380) , ANALYSIS(52685-380)