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

BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-039-31, 63354-039-34, 63354-039-37
Set ID 76782de6-a542-6f3e-e053-2a91aa0a5afd
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient

    Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 6%

  • 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.

  • Flammable

    Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Do not use in the 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.

  • May stain

    some fabrics.

  • Directions

    Shake well. 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. 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

  • Inactive Ingredients

    Water, Isobutane, Isohexadecane, C12-15 Alkyl 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

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    25% FEWER INGREDIENTS

    MADE WITHOUT OXYBENZONE & PARABENS

    tear free

    No Added Oils & Fragrances

    Water Resistant

    (80 Minutes)

    SHAKE WELL BEFORE USE

    BB Kids Simply Protect SPF 50+_9.5OZ

    BB Kids Simply Protect SPF 50+_6OZBB Kids Simply Protect SPF 50+_1.8 OZ

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    ISOBUTANE (UNII: BXR49TP611)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-039-3151 g in 1 CAN; Type 0: Not a Combination Product10/15/2018
    2NDC:63354-039-34170 g in 1 CAN; Type 0: Not a Combination Product10/15/2018
    3NDC:63354-039-37269 g in 1 CAN; Type 0: Not a Combination Product10/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/15/2018
    Labeler - Edgewell Personal Care Brands LLC (151179769)

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