Label: BANANA BOAT- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 63354-922-24
  • Packager: Edgewell Personal Care Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2023

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

View All Sections
  • 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

    May stain some fabrics.

    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.

  • Directions

    • Shake well • 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 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 • 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

    BANANA
    BOAT®
    baby
    mineral
    100% MINERAL BASED SUNSCREEN LOTION
    UVA/UVB BROAD SPECTRUM SPF 50+
    50+
    PEDIATRICIAN TESTED
    tear free
    NO OXYBENZONE & PARABENS
    Water Resistant
    (80 Minutes)
    6 FL. OZ. (177 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-922
    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
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-922-24177 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/02/2018
    Labeler - Edgewell Personal Care Brands, LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc963501502manufacture(63354-922)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!