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

BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-326-26
Set ID 4441ff7f-c3a1-4956-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Titanium Dioxide 4.5%, Zinc Oxide 6.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    If used as directed with 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 product is 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 •Children under 6 months: Ask a doctor

    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 value 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-sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8,Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • Other Information

    Protect this product form excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

  • Front Label

    Tear free • Sting Free

    BANANA

    BOAT

    baby

    UVA/UVB PROTECTION

    SUNSCREEN LOTION

    50

    BROAD SPECTRUM SPF 50

    Mineral based formula

    Gentle Formula

    Water resistant

    (80 MINUTES)

    SWIM • SPLASH • SPORT

    6335432626

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-326-26236 g in 1 TUBE; Type 0: Not a Combination Product01/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2017
    Labeler - Edgewell Personal Care Brands LLC (151179769)

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