BANANA BOAT (OCTOCRYLENE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]

BANANA BOAT (OCTOCRYLENE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC 63354-961-81
Set ID 4702f5cb-ac7a-1c4e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octocrylene 4%, Zinc Oxide 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 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. 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

  • Inactive ingredients

    Water, Ethylhexyl Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Phenoxyethanol, Sodium Chloride, Hydrogenated Castor Oil, Silica, Methylparaben, Triethoxycaprylylsilane, Dimethicone, Propylparaben, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate

  • Other Information

    protect this product from heat and direct sun

  • Questions or comments?

    Call 1-800-SAFESUN, Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    BANANA BOAT SPORT Performance FACES CLEAR ZINC SUNSCREEN UVA/UVB PROTECTION WONT CLOG PORES 50 WATER RESISTANT HYPOALLERGENIC (80 MINUTES) NON-GREASY BROAD SPECTRUM SPF 50 SWIM SPLASH SPORT

    6335496181

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-961
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-961-8156 g in 1 JAR; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2013
    Labeler - Edgewell Personal Care Brands LLC (151179769)

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