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

BANANA BOAT (AVOBENZONE HOMOSALATE OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]
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NDC 63354-314-10, 63354-314-18, 63354-314-21, 63354-314-22, 63354-314-56, 63354-314-57
Set ID 51f254be-d2ca-5040-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

  • 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

  • Do not use

    on damaged or broken skin.

  • When using this product

    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 Posion Control Center right away.

    May stain some fabrics

  • Directions

    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 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-sleeve shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor

  • Inactive Ingredients

    Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Methyl Dihydroabietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • 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

    SPORT

    Performance

    with POWERSTAY

    TECHNOLOGY

    sunscreen lotion

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 50+

    LIGHTWEIGHT FEEL

    WON'T RUN INTO EYES

    WATER & SWEAT

    RESISTANT (80 MINUTES)

    SWIM • SPLASH • SPORT

    633543145663354314576335431421633543142263354314186335431410

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone homosalate octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-314-57295 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2017
    2NDC:63354-314-18354 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2017
    3NDC:63354-314-56236 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2017
    4NDC:63354-314-2288 g in 1 TUBE; Type 0: Not a Combination Product06/05/201712/31/2017
    5NDC:63354-314-2159 g in 1 TUBE; Type 0: Not a Combination Product06/05/2017
    6NDC:63354-314-103628 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/05/2017
    Labeler - Edgewell Personal Care Brands, LLC (151179769)

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