Label: BANANA BOAT SPORT PERFORMANCE SPF 15- avobenzone and homosalate and octinoxate and octisalate and octocrylene and oxybenzone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 18, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 0.03mL / 1mL

    Homosalate 0.05mL / 1mL

    Octinoxate 0.05mL / 1mL

    Octisalate 0.05mL / 1mL

    Octocrylene 0.025mL / 1mL

    Oxybenzone 0.02mL / 1mL

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    • For external use only
    • Do not spray directly into face
    • Flammable do not use near heat, flame or while smoking
  • While using this product

    • Avoid spraying in eyes. If contact occurs rinse thoroughly with water.
    • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
  • Stop use and ask a doctor

    if irritation or rash develops

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison control center right way.

  • Directions

    • Apply generously and evenly to all areas 15 minutes before sun exposure
    • Spray on hands to apply to face
    • Use in well-ventilated area
    • Reapply at frequent intervals and after swimming or towel drying
    • Ask a doctor before use on children under six months of age
  • Other Information

    Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

    • May stain some fabrics.
  • Inactive Ingredients

    SD Alcohol 40-B, C12-15 Alkyl Benzoate, Acrylates/ Octylacrylamide, Copolymer, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Fragrance

  • Questions or comments?

    Call 1-800-SafeSun, Mon-Fri

    Distributed by:
    Sun Pharmaceuticals, LLC, Shelton, CT 06484
    www.bananaboat.com

    Manufactured by:
    Accra Pac, Inc. (dba KIK Custom Products)

  • PRINCIPAL DISPLAY PANEL

    CLEAR
    UltraMist®
    Banana
    Boat    ®
    SPORT
    PerformanceTM
    Active Dry     ProtectTM
    Continuous Spray Sunscreen
    SPF/UVB 15
    AvoTriplexTM
    High UVA
    Long-Lasting Protection
    Sun-Tested, Sun-    ProvenTM
    Invisible, Rub-Free
    Non-Greasy
    Very Water/Sweat     Resistant
    6 FL. OZ. (177     mL)

    PRINCIPAL DISPLAY PANEL Banana Boat Sport Performance SPF 15

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT SPORT PERFORMANCE SPF 15 
    avobenzone and homosalate and octinoxate and octisalate and octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.05 mL  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 mL  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.025 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2005-1177 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/02/2006
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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