BANANA BOAT PROTECTIVE DRY SPF 10 (HOMOSALATE AND OCTISALATE AND OCTOCRYLENE AND AVOBENZONE) OIL [ACCRA-PAC, INC.]

BANANA BOAT PROTECTIVE DRY SPF 10 (HOMOSALATE AND OCTISALATE AND OCTOCRYLENE AND AVOBENZONE) OIL [ACCRA-PAC, INC.]
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NDC 17630-2012-1
Set ID bd79e125-1b34-4b2e-8265-9fbf8ec0d74a
Category HUMAN OTC DRUG LABEL
Packager Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

  • Active Ingredients:

    Homosalate 0.06mL / 1mL

    Octisalate 0.06mL / 1mL

    Octocrylene 0.025mL / 1mL

    Avobenzone 0.015mL / 1mL

  • DIRECTIONS:

    Apply generously and evenly to all areas 20 minutes before sun exposure. No need to rub in. Reapply frequently to maintain protection and also after swimming and towel drying. Do not spray directly on face. Spray on hands to apply to face. Use in a well-ventilated area. For external use only. Avoid contact with eyes and clothes.

  • USAGE ADVICE:

    Do not stay too long in the sun even while using a sun protection product. Keep babies and young children out of direct sunlight. Use clothing and sun protection products with a very high SPF (higher than 25) for babies and young children. Over exposure to the sun is a serious health threat. Reducing applied quantity will significantly lower the level of protection.

  • WARNING:

    FLAMMABLE. Pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Do not spray on a naked flame, onto or near fire, or any incandescent material. Keep away from sources of ignition – no smoking. Use only as directed. Keep out of reach of children.

  • INGREDIENTS:

    Alcohol Denat., Homosalate, Ethylhexyl Salicylate, Paraffinum liquidum, Diethylhexyl 2, 6-Naphthalate, Octocrylene, Butyl Methoxydibenzoylmethane,Vitis vinifera, Cocos nucifera, Caprylyl Glycol, Acrylates/ Octylacrylamide Copolymer, Aloe barbadensis, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Parfum.

    FLAMMABLE
    MADE IN U.S.A
    DISTRIBUTED BY:
    ENERGIZER GROUP LTD
    SWORD HOUSE, HP13 6DG
    HIGH WYCOMBE, UK
    www.bananaboat.co.uk

  • PRINCIPAL DISPLAY PANEL

    CLEAR
    UltraMist®
    BANANA

    BOAT
    ®
    PROTECTIVE

    DRY OIL

    Continuous Spray Sun Protection

    SPF 10 UVA

    AvoTriplexTM
    Low Protection

    Sun-Tested, Sun-
    ProvenTM
    Fast & Even Coverage

    Coconut & Grape Seed Oils

    Very Water Resistant

    175 ml

    PRINCIPAL DISPLAY PANEL
Banana Boat Protective Dry Oil SPF 10

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT PROTECTIVE DRY SPF 10 
    homosalate and octisalate and octocrylene and avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.06 mL  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.06 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.025 mL  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.015 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2012-1175 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE

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