Label: BANANA BOAT SPORT SPF 30- homosalate, octinoxate, octisalate, octocrylene, oxybenzone and avobenzone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/10

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  • Active Ingredients

    Homosalate 0.0878mL / 1mL

    Octinoxate 0.05mL / 1mL

    Octisalate 0.05mL / 1mL

    Octocrylene 0.025mL / 1mL

    Oxybenzone 0.05mL / 1mL

    Avobenzone 0.03mL / 1mL

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  • DIRECTIONS:

    Apply generously and evenly to all areas 20 minutes before sun exposure. No need to rub in. Reapply at frequent intervals, 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. If contact occurs, rinse thoroughly with water. If irritation or rash appears, discontinue use. May stain some fabrics.

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  • 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.

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  • WARNING:

    FLAMMABLE. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. 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.

    Keep out of reach of children.

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  • INGREDIENTS:

    Alcohol Denat., Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Benzophenone-3, Butyl Methoxydibenzoylmethane, Octocrylene, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe barbadensis, Retinyl Palmitate, Dimethyl Capramide, Tocopherol, Parfum, Alpha-isomethyl Ionone, Amyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Limonene, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl 3-cyclohexene Carboxaldehyde, Linalool.

    Contains Oxybenzone.

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

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  • PRINCIPAL DISPLAY PANEL

    CLEAR
    UltraMist®
    BANANA

    BOAT
    ®
    SPORT

    ADVANCED
    AvoTriplex® UVA & UVB SUN PROTECTION
    SPF 30 UVA

    AvoTriplexTM
    High Protection

    Sun-Tested, Sun-
    ProvenTM
    Water Resistant

    Non-Greasy

    Quick Drying

    175 ml

    PRINCIPAL DISPLAY PANEL
Banana Boat Sport SPF 30

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  • INGREDIENTS AND APPEARANCE
    BANANA BOAT SPORT SPF 30 
    homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17630-2021
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (HOMOSALATE) HOMOSALATE 0.0878 mL  in 1 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 0.05 mL  in 1 mL
    OCTISALATE (OCTISALATE) OCTISALATE 0.05 mL  in 1 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.025 mL  in 1 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 0.05 mL  in 1 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    C12-15 ALKYL BENZOATE  
    CAPRYLYL GLYCOL  
    VITAMIN A PALMITATE  
    AMYL CINNAMAL  
    BENZYL BENZOATE  
    GERANIOL  
    ALOE VERA LEAF  
    LIMONENE, DL-  
    LINALOOL, DL-  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17630-2021-1 175 mL in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 06/09/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    Name Address ID/FEI Business Operations
    Accra-Pac, Inc. 024213616 MANUFACTURE
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