Label: BANANA BOAT SPORT PERFORMANCE ACTIVE DRY PROTECT SPF UVB 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 18, 2011

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  • ACTIVE INGREDIENT

    Drug Facts:

    Avobenzone:1.5%
    Homosalate: 15%
    Octisalate:  5%
    Octocrylene: 1.25%
    Oxybenzone:  5%


    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, Stearyl Alcohol, Glycerin, Capryly Glycol, Hydrogenated Dimer, Dilnoleyl Dimethyl Carbonate, Copolymer,
    Cetyl Alcohol, Triethanolamine, Behenyl Alcohol, Glyceryl Stearate, Glceryl Stearate Citrate, Disodium, Ethylene,
    Dicocamide PEG/15 Disulfate, Sodium Lauryl Sarcosinate, Carbomer, Xanthan Gum, Aloe Barbadenis Leaf Juice, Retinyl Palmitate,
    Tocophenol, Tocopheryl Acetate, Cetearyl Alcohol, Sodium Lauryl Lactylate, Leithin, BHT, Methyl Dibromo, Glutaronitrile, Methylchloroisothiazolinone,
    Methylisothiazolinone, Phenoxyl 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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
    IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE


    Directions:


    Apply generously and evenly to all areas 15 minutes before sun exposure.

    Re-Apply at frequent intervals and after swimming and towel drying.

    Ask a doctor for use on children under 6 months of age.

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT SPORT PERFORMANCE ACTIVE DRY PROTECT SPF UVB 50 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-831
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate53.1 mL  in 354 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate17.7 mL  in 354 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4.42 mL  in 354 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone17.7 mL  in 354 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone5.31 mL  in 354 mL
    Inactive Ingredients
    Ingredient NameStrength
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-831-83354 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/18/2011
    Labeler - KIK Custom Products (243547333)
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