Label: BANANA BOAT- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 63354-050-26, 63354-050-27
  • Packager: Energizer Personal Care LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

Drug Label Information

Updated 10/12

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

  • Active Ingredients

    Titanium Dioxide 3.1%
    Zinc Oxide 4.0%

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • if used as directed wiht other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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  • Warnings

    • For external use only
    • 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.

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  • Stop use and ask a doctor

    if rash occurs

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    May stain some fabrics.

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulatory 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 a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
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  • Other information

    • protect this product from excessive heat and direct sun
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  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

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  • Principal Display Panel

    Banana Boat

    Baby

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Proven to be Gentle

    Water Resistant (80 minutes)

    Recommended Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Play

    8 FL. OZ. (236 mL)

    Bonus 25% More

    Banana Boat

    Baby

    Tear Free Sting Free

    UVA/UVB Protection

    Sunscreen Lotion

    50

    Broad Spectrum SPF 50

    Pediatrician Tested

    Proven to be Gentle

    Water Resistant (80 minutes)

    Recommended Skin Cancer Foundation

    Active

    Recommended as an effective UV sunscreen

    Swim Splash Play

    10 FL. OZ. (295 mL)

    BB Baby SPF 50 8 oz

    BB Baby SPF 50 10 oz

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  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63354-050
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.1 g  in 100 g
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    MEDIUM-CHAIN TRIGLYCERIDES  
    ISOHEXADECANE  
    BUTYLOCTYL SALICYLATE  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)  
    SODIUM CHLORIDE  
    ETHYLHEXYL METHOXYCRYLENE  
    DIMETHICONE  
    CAPRYLYL GLYCOL  
    POLYETHYLENE GLYCOL 400  
    ALUMINUM OXIDE  
    GLYCERIN  
    SODIUM CITRATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    ALOE VERA LEAF  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-050-26 236 g in 1 TUBE
    2 NDC:63354-050-27 295 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/03/2012
    Labeler - Energizer Personal Care LLC (021718141)
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