BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]
PDF | XML

NDC 63354-925-31, 63354-925-34, 63354-925-36, 63354-925-37
Set ID 61cca28e-8fbc-c312-e053-2a91aa0a64e0
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 6%

  • 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

    •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 and then apply to face. •Do not apply in windy conditions •Use in a well-ventilated area •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, Isobutane, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

  • 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

    simply

    protect

    Kids

    sunscreen lotion spray

    50+

    25% fewer ingredients*

    made without oxybenzone & parabens

    no added oils & fragrances

    broad spectrum SPF 50+

    water resistant (80 minutes)

    6335492536

    633549253163354925346335492537

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-925
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ISOBUTANE (UNII: BXR49TP611)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-925-34170 g in 1 CAN; Type 0: Not a Combination Product01/02/2018
    2NDC:63354-925-3151 g in 1 CAN; Type 0: Not a Combination Product01/02/2018
    3NDC:63354-925-37269 g in 1 CAN; Type 0: Not a Combination Product01/02/2018
    4NDC:63354-925-36212 g in 1 CAN; Type 0: Not a Combination Product04/01/2018
    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
    KIK Custom Product243547333manufacture(63354-925)

Related Drugs