Label: BANANA BOAT QUIK DRI SPORT BODY AND SCALP SPF 30- avobenzone and octocrylene and oxybenzone lotion

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 27, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 0.01mL / 1mL

    Octocrylene 0.077mL / 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

    do not get into eyes. If contact occurs, rinse thoroughly with water.

    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  
    • 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, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl, Thiosulfate Silica, Octyldodecanol, Silica, Fragrance

    Call 1-800-SAFESUN, M-F
    Dist. by: SUN PHARMACEUTICALS, LLC

  • PRINCIPAL DISPLAY PANEL

    BANANA
    BOAT    ®
    QUIK DRI
    SPORT
    Body & Scalp
    Advanced UVA/UVB Sunscreen
    SPF/UVB 30 Infused with Pure Aloe Vera*
    AvoTriplexTM
    High UVA
    Long-Lasting Protection
    Sun-Tested, Sun-    ProvenTM
    Non-Greasy, Oil-Free
    Won’t Run Into Eyes
    Very Water/Sweat Resistant
    6 FL. OZ. (177mL)

    PRINCIPAL DISPLAY PANEL Banana Boat Quik Dri Sport Body and Scalp SPF 30

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT QUIK DRI SPORT BODY AND SCALP SPF 30 
    avobenzone and octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.01 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.077 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2028-1177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/09/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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