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 63354-755-01, 63354-755-21, 63354-755-54, 63354-755-56
Set ID 441a46f0-ecda-4448-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
    • 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 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • 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, Methyl Dihydroabietate,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

  • Front Label

    BANANA

    BOAT®

    NEW

    LOOK!

    KiDS

    SPORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPRECTRUM SPF 50+

    50+

    with

    POWERSTAY

    TECHNOLOGY™

    tear+sting free

    High Endurance vs. Sweat & Water

    Water Resistant

    (80 Minutes)

    6 FL.OZ. (177 mL)

    X300728301

    BANANA

    BOAT®

    NEW

    LOOK!

    KiDS

    SPORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPRECTRUM SPF 50+

    50+

    with

    POWERSTAY

    TECHNOLOGY™

    tear+sting free

    High Endurance vs. Sweat & Water

    Water Resistant

    (80 Minutes)

    1 FL.OZ. (29 mL)

    X300748501

    BANANA

    BOAT®

    NEW

    LOOK!

    KiDS

    SPORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPRECTRUM SPF 50+

    50+

    with

    POWERSTAY

    TECHNOLOGY™

    tear+sting free

    High Endurance vs. Sweat & Water

    Water Resistant

    (80 Minutes)

    0.4 FL.OZ. (11.8 mL)

    X300753401

    BONUS

    25% MORE

    7.5 oz vs 6 oz

    BANANA

    BOAT®

    NEW

    LOOK!

    KiDS

    SPORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPRECTRUM SPF 50+

    50+

    with

    POWERSTAY

    TECHNOLOGY™

    tear+sting free

    High Endurance vs. Sweat & Water

    Water Resistant

    (80 Minutes)

    7.5 FL.OZ. (221.8 mL)

    X300808701

    50%

    MORE

    FAMILY SIZE!

    9 OZ VS 6 OZ

    BANANA

    BOAT®

    NEW

    LOOK!

    KiDS

    SPORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPRECTRUM SPF 50+

    50+

    with

    POWERSTAY

    TECHNOLOGY™

    tear+sting free

    High Endurance vs. Sweat & Water

    Water Resistant

    (80 Minutes)

    9 FL.OZ. (270 mL)

    X301348400 Front

    X301348400 Back

    WITH

    POWERSTAY

    TECHNOLOGY™

    BANANA

    BOAT

    KIDS

    SPORT

    SUNSCREEN LOTION

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 50+

    Tear free • sting free

    WATER RESISTANT

    (80 MINUTES)

    6335475521633547555463354755566335475501

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-755
    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
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-755-0111 g in 1 PACKET; Type 0: Not a Combination Product01/02/2017
    2NDC:63354-755-2129 g in 1 TUBE; Type 0: Not a Combination Product01/02/2017
    3NDC:63354-755-54177 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2017
    4NDC:63354-755-56221 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2017
    5NDC:63354-755-27270 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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