Label: BANANA BOAT SPORT BODY AND SCALP SPF 30- homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone 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 26, 2010

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  • SPL UNCLASSIFIED SECTION

  • 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

  • DIRECTIONS:

    Apply generously and evenly (equivalent to 3 tablespoons) to all areas before sun exposure. Spray on hands to apply to face. Do not spray on face. Reapply at frequent intervals, after swimming and towel drying. For external use only. Avoid contact with eyes and fabrics.

  • 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.

  • CAUTION:

    Over-exposure to the sun is a serious health threat. Reducing applied quantity will lower the level of protection significantly.

  • WARNING:

    FLAMMABLE. DO NOT SPRAY ON NAKED FLAME OR ANY INCANDESCENT MATERIAL. KEEP AWAY FROM FLAMES, SPARKS OR SOURCES OF IGNITION.

    KEEP OUT OF REACH OF CHILDREN.

  • INGREDIENTS:

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

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

  • PRINCIPAL DISPLAY PANEL

    BANANA
    BOAT    ®
    QUICK DRY
    SPORT
    Body & Scalp
    Rub-Free Sun Protection Spray
    SPF 30 UVA
    AvoTriplexTM
    High Protection
    Sun-Tested, Sun-    ProvenTM
    Sweat & Water
    Resistant
    Broad Spectrum
    180 ml     

    PRINCIPAL DISPLAY PANEL Banana Boat Sport Body and Scalp SPF 30

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT SPORT BODY AND SCALP SPF 30 
    homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.0878 mL  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 mL  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.025 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.05 mL  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    AMYL CINNAMAL (UNII: WC51CA3418)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    GERANIOL (UNII: L837108USY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIMONENE, DL- (UNII: 9MC3I34447)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2020-1180 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/09/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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