Label: BANANA BOAT KIDS PROTECT AND PLAY SPF 85- avobenzone, homosalate, octocrylene and oxybenzone spray 

  • Label RSS
  • NDC Code(s): 17630-2016-1, 17630-2016-2
  • Packager: Accra-Pac, Inc.
  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

    Avobenzone 0.03mL / 1mL

    Homosalate 0.15mL / 1mL

    Octocrylene 0.10mL / 1mL

    Oxybenzone 0.06mL / 1mL

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  • Purpose

    Sunscreen

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  • Use

    helps prevent sunburn

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  • 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.

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  • 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
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  • 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.
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  • Inactive Ingredients

    SD Alcohol 40-B, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/Tricaprate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Fragrance.

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  • Questions or Comments?

    Call 1-800 SafeSun, Mon-Fri

    Dist. by:
    SUN PHARMACEUTICALS, LLC
    SHELTON, CT 06484

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  • PRINCIPAL DISPLAY PANEL

    CLEAR
    UltraMist®
    BANANA

    BOAT
    ®
    KiDS
    Protect &
    PlayTM
    Continuous Spray Sunscreen

    SPF/UVB 85

    PEDIATRICIAN TESTED
    AvoTriplexTM
    High UVA

    Long-Lasting Protection

    Sun-Tested, Sun-
    ProvenTM
    Invisible, Rub-Free

    Hypoallergenic

    Very Water/Sweat Resistant

    6 FL. OZ. (177
    mL)

    PRINCIPAL DISPLAY PANEL
Banana Boat Kids Protect and Play SPF 85

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  • INGREDIENTS AND APPEARANCE
    BANANA BOAT KIDS PROTECT AND PLAY SPF 85 
    avobenzone and homosalate and octocrylene and oxybenzone spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17630-2016
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 mL  in 1 mL
    HOMOSALATE (HOMOSALATE) HOMOSALATE 0.15 mL  in 1 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.10 mL  in 1 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 0.06 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CYCLOMETHICONE 5  
    CYCLOMETHICONE 6  
    DICAPRYLYL CARBONATE  
    CAPRYLYL GLYCOL  
    ALOE VERA LEAF  
    VITAMIN A PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17630-2016-1 177 mL in 1 CAN
    2 NDC:17630-2016-2 236 mL in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 06/01/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    Name Address ID/FEI Business Operations
    Accra-Pac, Inc. 024213616 MANUFACTURE
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