BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]

BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ENERGIZER PERSONAL CARE LLC]
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NDC 63354-050-26, 63354-050-27
Set ID decfb4bd-c7aa-46eb-ac08-eee56ef4390f
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Energizer Personal Care LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Titanium Dioxide 3.1%
    Zinc Oxide 4.0%

  • Purpose

    Sunscreen

  • 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.

  • Warnings

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

    May stain some fabrics.

  • 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
  • Other information

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

    Call 1-800-SafeSun, Mon-Fri

  • 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

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63354-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-050-26236 g in 1 TUBE
    2NDC:63354-050-27295 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/03/2012
    Labeler - Energizer Personal Care LLC (021718141)

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