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 63354-795-21, 63354-795-54, 63354-795-56
Set ID 283388e7-b5c7-6c45-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 5.0%, Octocrylene 4.0%

  • 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.

  • D o 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.

  • OTHER SAFETY INFORMATION

    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 •Children under 6 months: Ask a doctor

  • Inactive ingredients

    Water, Ethylhexyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Fragrance, Coco- Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, 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

  • PDP

    6335479554

    6335479521

    6335479556

    BANANA BOAT

    SunComfort

    Sunscreen Lotion

    Sand easily brushes off/ Relieves dryness

    UVA/UVB PROTECTION

    BROAD PECTRUM SPF 30

    GOOD FOR EVERYDAY US

    LIGHTWEIGHT

    WATER RESISTANT

    (80 MINUTES)

    SWIM SPLASH SPORT

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone homosalate octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-795
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-795-2129 g in 1 TUBE; Type 0: Not a Combination Product10/15/2015
    2NDC:63354-795-54177 g in 1 BOTTLE; Type 0: Not a Combination Product10/15/2015
    3NDC:63354-795-56221 g in 1 BOTTLE; Type 0: Not a Combination Product10/15/201512/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/15/2015
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc.963501502manufacture(63354-795)

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