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Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen (Elizabeth Arden, Inc)

Available Formats

Dosage Form Package Information Links
LOTION 1 TUBE in 1 BOX (67938-1094-1) > 53 g in 1 TUBE (67938-1094-2) Label Information

Complete Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen Information

  • DESCRIPTION

    Provides powerful SPF 50 PA+++ protection to shield against UVA/UVB rays that can cause sunburn, surface skin cell damage and premature signs of aging. Lightweight, oil-free lotion helps protect your skin from sun exposure while hydrating for up to 8 hours. PABA free.

    Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

    Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.


  • INDICATIONS AND USAGE

    Directions: Apply liberally and evenly to face 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.


  • WARNINGS

    Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is 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.


  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide 11.62% w/w, Octinoxate 7.40% w/w, Octisalate 5.00% w/w.


  • INACTIVE INGREDIENT

    Water/Aqua/Eau, C12-25 Alkyl Benzoate, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Caprlyl Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Arachidyl Glucoside, Triethoxycaprylylsilane, Behenyl Alcohol, Xanthan Gum, BHT, Disodium EDTA, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Methylparaben, Phenoxyethanol, Sorbic Acid.


  • DOSAGE & ADMINISTRATION

    Apply liberally and evenly to face.


  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.


  • OTC - PURPOSE

    Helps prevent sunburn. Higher SPF gives more sunburn protection.


  • OTC - WHEN USING

    Keep out of eyes.


  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1094
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.159 g  in 53 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.922 g  in 53 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.65 g  in 53 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SORBIC ACID (UNII: X045WJ989B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67938-1094-1 1 in 1 BOX
    1 NDC:67938-1094-2 53 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 12/14/2010
    Labeler - Elizabeth Arden, Inc (849222187)