EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 (HOMOSALATE) STICK [ELIZABETH ARDEN, INC]

EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 (HOMOSALATE) STICK [ELIZABETH ARDEN, INC]
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NDC 67938-1130-1, 67938-1130-2
Set ID b8bcb692-3a6c-4c57-8fd2-1298011bd245
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • DESCRIPTION

    Target over-exposed areas such as lips, nose, earlobes, even scars to shield from the burning and aging effects of UVA and UVB rays. Eight Hour Cream hydrating benefits sooth and smooth for up to 8 hours.

    Oil-free. Water-resistant. PABA-free. Non-acnegenic. Perspiration-resistant. Suitable for all skin types. Ophthalmologist, clinically and dermatologist tested.

    Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or perspiring.

    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 targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. 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 if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a poison controll center right away.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Homosalate 7.5% w/w, Octinoxate 7.5% w/w, Octocrylene 5.0% w/w, Oxybenzone 4.0% w/w, Avobenzone 2.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Octyldodecyl Myristate, Polyethylene, Phenyl Trimethicone, Tocopheryl Acetate, Caprylyl Glycol, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Phenoxyethanol.

  • DOSAGE & ADMINISTRATION

    Apply evenly and liberally to targeted areas.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    Helps prevent sunburn. Higher SPF gives more sun protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

     Eight Hour Cream Targeted Sun Defense Stick Box

     Eight Hour Cream Targeted Sun Defense Stick Tube

     

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 
    homosalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.51 g  in 6.8 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.51 g  in 6.8 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.34 g  in 6.8 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.27 g  in 6.8 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.14 g  in 6.8 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1130-11 in 1 BOX
    1NDC:67938-1130-26.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/12/2010
    Labeler - Elizabeth Arden, Inc (849222187)

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