Label: BENEFIANCE PROTECTIVE HAND REVITALIZER- octinoxate 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 09/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    OCTINOXATE 7.4%

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  • Purpose

    Sunscreen

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  • Use

    • helps prevent sunburn
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  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
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  • Inactive Ingredients

    WATER, DIPROPYLENE GLYCOL, DIMETHICONE, BUTYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, STEARYL ALCOHOL, HYDROGENATED PALM OIL, PEG-5 GLYCERYL STEARATE, BENTONITE, GLYCERIN, SQUALANE, TRANEXAMIC ACID, TRIMETHYLSILOXYSILICATE, XANTHAN GUM, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, TOCOPHERYL ACETATE, POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE, MAGNESIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, SAXIFRAGA SARMENTOSA EXTRACT, STEARIC ACID, ISOSTEARIC ACID, BEHENIC ACID, CYCLOMETHICONE, TRISODIUM EDTA, SODIUM CITRATE, POTASSIUM HYDROXIDE, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, ETHYLPARABEN, BUTYLPARABEN, FRAGRANCE, IRON OXIDES,

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  • Other information

    • protect this product in this container from excessive heat and direct sun.
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  • Questions or comments?

    Call toll free 1-800-906-7503

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  • PRINCIPAL DISPLAY PANEL - 75g Tube Carton

    SHISEIDO

    Shiseido
    Benefiance

    Protective
    Hand Revitalizer (Cream)
    SPF 10
    SUNSCREEN

    75g NET WT. 2.6 OZ.

    PRINCIPAL DISPLAY PANEL - 75g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    BENEFIANCE PROTECTIVE HAND REVITALIZER 
    octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52686-106
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 5550 mg  in 75 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DIPROPYLENE GLYCOL  
    DIMETHICONE  
    BUTYLENE GLYCOL  
    DIPHENYLSILOXY PHENYL TRIMETHICONE  
    STEARYL ALCOHOL  
    HYDROGENATED PALM OIL  
    PEG-5 GLYCERYL STEARATE  
    BENTONITE  
    GLYCERIN  
    SQUALANE  
    TRANEXAMIC ACID  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)  
    XANTHAN GUM  
    .ALPHA.-TOCOPHEROL ACETATE  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE  
    MAGNESIUM ASCORBYL PHOSPHATE  
    HYALURONATE SODIUM  
    SAXIFRAGA STOLONIFERA LEAF  
    STEARIC ACID  
    ISOSTEARIC ACID  
    BEHENIC ACID  
    CYCLOMETHICONE  
    EDETATE TRISODIUM  
    SODIUM CITRATE  
    POTASSIUM HYDROXIDE  
    ALCOHOL  
    BUTYLATED HYDROXYTOLUENE  
    TOCOPHEROL  
    PHENOXYETHANOL  
    ETHYLPARABEN  
    BUTYLPARABEN  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52686-106-60 1 in 1 CARTON
    1 75 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 10/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    Name Address ID/FEI Business Operations
    SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-106), ANALYSIS(52686-106)
    Establishment
    Name Address ID/FEI Business Operations
    Davlyn Industries Inc 624436254 MANUFACTURE(52686-106)
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