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 63354-813-21, 63354-813-54
Set ID 43796c72-2321-4ca8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 2.2%

    Homosalate 7.0%

    Octocrylene 4.2%

  • 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. 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

    Children under 6 months:Ask a doctor

  • Inactive Ingredients

    Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside,Methylparaben, Fragrance, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Polymethylsilsesquioxane, 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

    Dry

    Balance

    Sunscreen lotion

    Helps you feel

    Dry & Fresh

    30

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 30

    SOFT MATTE FINISH

    SKIN BREATHES EASY

    WATER RESISTANT

    (80 MINUTES)

    6335481321

    6335481354

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-813-54177 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2017
    2NDC:63354-813-2129 g in 1 BOTTLE; Type 0: Not a Combination Product01/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2017
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex manufacturing Inc963501502manufacture(63354-813)

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