Label: BANANA BOAT ULTRA DEFENSE BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2010

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  • ACTIVE INGREDIENT

    Drug Facts:

    Avobenzone:     1.5%
    Homosalate:       15%
    Octisalate:            5%
    Octicrylene:        1.25%
    Oxybenzone:    6%

    Purpose:  Sunscreen

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT, DO NOT GET INTO EYES IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
    STOP USE AND ASK DOCTOR IS IRRITATION OR RASH DEVELOPS.  KEEP OUT OF REACH OF CHILDREN.
    IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

  • INACTIVE INGREDIENT

    Water, Cetearyl Alcohol, Glycerin, Capryly Glycol, Hydrogenated Dimer Dilnoleyl/Dimethyl Carbonate,
    Copolymer, Cetyl Alcohol, Triethanolamine, Behenyl Acohol, Glyceryl Stearate, Glyceryl Stearate, Citrate,
    Disodium Ethylene, Dicocamide PEG-15 Disulfate, Sodium Lauroyl Sarcosinate, Carbomer, Xanthan Gum,
    Aloe Barbadensis Leaf Juice, Retinyl Palmitate (Vitamin A), Tocopherol, Tocopheryl Acetate (Vitamin E),
    Cetearyl Alchol, Sodium Lauroyl, Lactylate, Lecithin, BHT, Methyl Dibromo Glutaronitrile, Methyl Chloisothiazolinone.
    Methyl Isothiazolinone, Phenoxy Ethanol, Dipropylene Glycol, Disodium EDTA

  • QUESTIONS

    Questions or Comments:  Call 1-800-SAFESUN Mon-Fri.

  • PRINCIPAL DISPLAY PANEL

    Image of Tube Label - Back

    Image of Tube Label - Front

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT ULTRA DEFENSE BROAD SPECTRUM 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.36 mL  in 236 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate35.4 mL  in 236 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate11.8 mL  in 236 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.95 mL  in 236 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone14.16 mL  in 236 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-811-72236 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/23/2010
    Labeler - KIK Custom Products (243547333)
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