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 63354-191-54
Set ID 775a4242-9efb-256a-e053-2991aa0ae37a
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 9.0%, Octocrylene 5.0%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by 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 Poison 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 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 • Children under 6 months: Ask a doctor.

  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Coco-Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, Fragrance, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, 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

    Sun

    COMFORT

    SUNSCREEN LOTION

    UVA/UVB BROAD SPECTRUM SPF 50+

    50+

    Sand Easily

    Brushes Off

    RELIEVES DRYNESS

    High Endurance vs. Water

    Water Resistant

    (80 Minutes)

    BB SPF 50+ Lotion

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-191-54177 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/05/2018
    Labeler - Edgewell Personal Care Brands LLC (151179769)

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