BANANA BOAT SPORT PERFORMANCE SPF 15 (AVOBENZONE AND HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]

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  • BANANA BOAT SPORT PERFORMANCE SPF 15 (AVOBENZONE AND HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]

BANANA BOAT SPORT PERFORMANCE SPF 15 (AVOBENZONE AND HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]
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NDC 17630-2005-1
Set ID a742a01f-20f9-4d1d-b0f8-85f716c6ea61
Category HUMAN OTC DRUG LABEL
Packager Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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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