Label: BANANA BOAT- avobenzone homosalate octocrylene spray

  • NDC Code(s): 63354-190-34
  • 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 November 1, 2017

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  • Active Ingredients

    Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

  • 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.

  • Flammable

    Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking. Intentional misuse by deliberately concentrating or 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.

  • May stain

    some fabrics.

  • 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 area. reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. Sun Protection Measures: Spendting 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 includingL limit time in the sun, especially from 10 a.m.-2 p.m., wear long-sleeve shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor.

  • Inactive Ingredients

    Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Caprylyl Glycol, Methyl Dihydroabietate, Ascorbyl Palmitate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract, Fragrance.

  • Other Information

    protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call 1 800 SafeSun, Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    CLEAR

    UltraMist

    Banana

    Boat

    SPORT

    Performance

    With POWERSTAY

    TECHNOLOGY

    continuous spray sunscreen

    15

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 15

    HEAVY-DUTY PROTECTION

    ULTRA-LIGHTWEIGHT FEEL

    WATER & SWEAT RESISTANT

    (80 MINUTES)

    SWIM SPLASH SPORT

    6335419034.jpg

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone homosalate octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-190-34170 g in 1 CAN; Type 0: Not a Combination Product04/07/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/07/2015
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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