BANANA BOAT PROTECTIVE DRY SPF 15 (AVOBENZONE AND OCTOCRYLENE AND OXYBENZONE) OIL [ACCRA-PAC, INC.]

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BANANA BOAT PROTECTIVE DRY SPF 15 (AVOBENZONE AND OCTOCRYLENE AND OXYBENZONE) OIL [ACCRA-PAC, INC.]
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NDC 17630-2017-1
Set ID d37904c7-4e22-453b-8e72-92e77983d653
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

    Octocrylene  0.05mL / 1mL

    Oxybenzone 0.03mL / 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

    When 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 away.

  • 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, Mineral Oil, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/ Tricaprate, Ethylhexyl Benzoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Cetearyl Ethylhexanoate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Aloe Barbadensis Leaf Extract, Fragrance

  • Questions or Comments?

    Call 1-800 SafeSun, Mon-Fri

    MADE IN USA
    Distributed by:
    SUN PHARMACEUTICALS CORP.
    P.O. BOX 7869
    DELRAY BEACH, FL 33482

  • PRINCIPAL DISPLAY PANEL

    CLEAR
    UltraMist®
    BANANA
    BOAT    ®
    protective
    TANNING
    DRY OIL
    Continuous Spray Sunscreen
    SPF/UVB 15
    AvoTriplexTM
    High UVA
    3-Way     ProtectionTM
    Sun-Tested, Sun-    ProvenTM
    Fast & Even Coverage
    Coconut & Grape Seed Oils
    Very Water Resistant
    6 FL. OZ. (177     mL)

    PRINCIPAL DISPLAY PANEL Banana Boat Protective Dry Oil SPF 15

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT PROTECTIVE DRY SPF 15 
    avobenzone and octocrylene and oxybenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.05 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2017-1177 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/17/2008
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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