Label: BANANA BOAT- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 63354-924-21, 63354-924-24, 63354-924-26, 63354-924-27
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 3, 2020

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

  • Active Ingredients

    TITANIUM DIOXIDE 4.5%
    ZINC OXIDE 6.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only

    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.

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of eyes. Keep away from face to avoid breathing it. 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

  • 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.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-SAFESUN, Mon-Fri

  • Principal Display Panel

    NEW!

    25% MORE

    VALUE SIZE

    tear free

    BANANA

    BOAT (R)

    simply

    protect (TM)

    KiDS

    MINERAL-BASED SUNSCREEN LOTION

    50+

    25% fewer ingredients*

    MADE WITHOUT OXYBENZONE & PARABENS

    NO ADDED OILS & FRAGRANCES

    BROAD SPECTRUM SPF 50+

    WATER RESISTANT (80 MINUTES)

    7.5 FL. OZ. (221.8 mL)

    63354-924-26

    50%

    MORE

    FAMILY SIZE!

    9 OZ VS 6 OZ

    BANANA

    BOAT®

    NEW

    LOOK!

    simply

    protect™

    KiDS

    MINERAL BASED SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS*

    MADE WITHOUT OXYBENZONE & PARABENS

    tear free

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    9 FL. OZ. (270 mL)

    X301020201

    BANANA

    BOAT®

    NEW

    LOOK!

    simply

    protect™

    KiDS

    MINERAL BASED SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS*

    MADE WITHOUT OXYBENZONE & PARABENS

    tear free

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    1 FL. OZ. (29 mL)

    X301020301

    BANANA

    BOAT®

    NEW

    LOOK!

    simply

    protect™

    KiDS

    MINERAL BASED SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS*

    MADE WITHOUT OXYBENZONE & PARABENS

    tear free

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    6 FL. OZ. (177 mL)

    X301297200

    Tear free

    Banana

    Boat

    simply

    protect

    kids

    mineral based sunscreen lotion

    50+

    25% fewer ingredients*

    made without oxybenzone & parabens

    no added oils & fragrances

    broad spectrum spf 50+

    water resistant (80 minutes)

    6335492421

    6335492424

    6335492427

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-924
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-924-2129 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    2NDC:63354-924-24177 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    3NDC:63354-924-27270 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    4NDC:63354-924-267.5 g in 1 TUBE; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2018
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc963501502manufacture(63354-924)