Label: LEADER DARK TANNING SPF 4- octinoxate and oxybenzone aerosol, spray 

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  • 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 01/13

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

  • Active Ingredients

    Octinoxate 2.0%, Oxybenzone 0.5%

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  • Purpose

    Sunscreen

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  • Uses

    • 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

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  • FLAMMABLE

    • do not use near heat, flame or while smoking
    • avoid long term storage above 104°F (40°C)
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  • Do not use

    on damaged or broken skin

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  • When using this product

    keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F.

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  • Stop use and ask a doctor

    if rash occurs.

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  • 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

    Apply liberally 15 minutes before sun exposure

    Hold can 4-6 inches away from body, spray evenly to ensure complete coverage

    Do not spray into face. Spray into hand and apply to face.

    Use in well ventilated, but not windy areas

    Reapply:

    After 80 minutes of swimming or sweating

    Immediately after towel drying

    At least every 2 hours

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  • Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 am - 2 pm

    wear long sleeve shirts, pants, hats, and sunglasses

    Children under 6 months: ask a doctor

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  • Inactive Ingredients

    Alcohol denat., C12-15 alkyl benzoate, aloe barbadensis leaf juice, retinyl palmitate (vitamin A), ascorbic acid (vitamin C), tocopheryl acetate (vitamin E), daucus carota sativa (carrot) root extract, acrylates/octylacrylamide copolymer, fragrance

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  • Questions or Comments?

    Call toll free 1-800-200-6313

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  • Label

    Image of labelLabel8.jpg

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  • INGREDIENTS AND APPEARANCE
    LEADER  DARK TANNING SPF 4
    octinoxate, oxybenzone aerosol, spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-722
    Route of Administration Topical DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 16.6 mg  in 1 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 4.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    CARROT JUICE  
    C12-15 ALKYL BENZOATE  
    ASCORBIC ACID  
    VITAMIN A PALMITATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    ALOE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-722-30 177 mL in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/15/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Fruit of the Earth (008193513)
    Establishment
    Name Address ID/FEI Business Operations
    Fruit of the Earth 008193513 manufacture(37205-722)
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