Label: BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 63354-010-34, 63354-010-36, 63354-010-37
  • 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 28, 2017

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

  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 6%

    Close
  • Purpose

    Sunscreen

    Close
  • Uses

    helps prevent sunburn

    Close
  • Warnings

    • For external use only
    • Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Do not use in presence of a flame or spark. Keep away from sources of ignition - No smoking.
    • Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
    • Do not use on damaged or broken skin

    When using this product

    • keep away from face to avoid breathing it
    • 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.

    Close
  • Directions

    • hold container 4 to 6 inches from the skin to apply
    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • do not spray directly into face. Spray on hands then apply to face.
    • do not apply in windy conditions
    • use in well ventilated are
    • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
    Close
  • Other Information

    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 am - 2 pm
    • wear long-sleeve shirts, pants, hats and sunglasses
    • May stain some fabrics.
    Close
  • Inactive Ingredients

    Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

    Close
  • Questions or Comments?

    Call 1-800 SafeSun, Mon-Fri

    Close
  • Principal Display Panel

    LOTION

    UltraMist®

    Tear-Free

    Sting-Free

    BANANA
    BOAT®

    KIDS


    UVA/UVB PROTECTION

    CONTINUOUS SPRAY SUNSCREEN


    50+


    BROAD SPECTRUM
    SPF 50+


    WATER RESISTANT
    (80 MINUTES)

    NO ADDED FRAGRANCE

    SWIM•SPLASH•SPORT


    NET WT.

    6335401037

    Close
  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-010-34 177.42 g in 1 CAN; Type 0: Not a Combination Product 01/11/2012
    2 NDC:63354-010-36 236.56 g in 1 CAN; Type 0: Not a Combination Product 01/11/2012
    3 NDC:63354-010-37 269 g in 1 CAN; Type 0: Not a Combination Product 01/11/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/11/2012
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Close