BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [EDGEWELLPERSONAL CARE BRANDS LLC]

BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [EDGEWELLPERSONAL CARE BRANDS LLC]
PDF | XML

NDC 63354-219-23
Set ID 353353b9-54f8-4300-9632-7615de394076
Category HUMAN OTC DRUG LABEL
Packager EdgewellPersonal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

  • 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 eyse. 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

    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.

  • Other information

    protect this product from excessive heat and direct sun

  • Qestions or comments?

    Call 1-800-SafeSun, Mon-Fri

  • Inactive Ingredients

    Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate,Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Chloride, Benzyl Alcohol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methylparaben, Microcrystalline Wax, Polyethylene, Caprylyl Glycol, Propylparaben,Disodium EDTA, Stearoxy Dimethicone, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

  • PRINCIPAL DISPLAY PANEL

    BANANA

    BOAT

    KIDS

    MAX Protect & Play

    UVA/UVB PROTECTION

    SUNSCREEN LOTION

    100

    BROAD SPECTRUM

    SPF 100

    WATER RESISTANT

    (80 MINUTES)

    PROTECTS FROM 99% OF BURNING RAYS

    WON'T RUN INTO EYES

    SWIM SPLASH SPORT

    6335421923

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-219-23118 g in 1 TUBE; Type 0: Not a Combination Product11/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/19/2012
    Labeler - EdgewellPersonal Care Brands LLC (151179769)

Related Drugs