Label: BANANA BOAT ULTRAMIST KIDS TEAR FREE LOTION SPF 50- homosalate and octinoxate and octisalate and octocrylene and avobenzone spray

  • 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 21, 2010

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  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENTS:

    Homosalate 0.1mL / 1mL

    Octinoxate 0.075mL / 1mL

    Octisalate 0.05mL / 1mL

    Octocrylene 0.05mL / 1mL

    Avobenzone 0.03mL / 1mL

  • DIRECTIONS:

    Apply generously and evenly to all areas 20 minutes before sun exposure. Do not spray on face. Spray on hands to apply to face. Use in a well-ventilated area. Reapply at frequent intervals, after swimming, perspiring and towel drying.

  • USAGE ADVICE:

    Do not stay too long in the sun even while wearing sun protection. Keep babies and young children out of direct sunlight. Wearing protective clothing and very high SPF (higher than 25) sun protection is important for babies and young children. Over-exposure to the sun is a serious health threat. For external use only. Avoid contact with eyes. If irritation or rash appears, discontinue use.

  • WARNING:

    Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Keep out of reach of children.

  • INGREDIENTS:

    Aqua, Isohexadecane, Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Octocrylene, Cetyl PEG/PPG-10/1 Dimethicone, Butyl Methoxydibenzoylmethane, Bis-ethylhexyloxyphenol Methoxyphenyl Triazine, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylyl Glycol, Glucose, Caprylic/Capric Triglycerides, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Sodium Chloride, Disodium EDTA, Lactoperoxidase, Glucose Oxidase, Aloe barbadensis, Retinyl Palmitate,Sodium Citrate, Tocopheryl Acetate, Tocopherol, Sodium Ascorbyl Phosphate.

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

    Manufactured by:
    Accra Pac, Inc (dba KIK Custom Products)

  • PRINCIPAL DISPLAY PANEL

    LOTION
    UltraMist®
    Banana
    Boat    ®
    Kids
    Tear Free
    ADVANCED UVA/UVB SPRAY SUN PROTECTION
    SPF 50 UVA
    AvoTriplex
    High     ProtectionTM
    Sun-Tested, Sun-    ProvenTM
    Fast & Even Coverage
    Continuous Lotion Spray
    Water Resistant
    175 ml

    PRINCIPAL DISPLAY PANEL Banana Boat UltraMist Kids Tear Free Lotion Spray SPF 50

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT ULTRAMIST KIDS TEAR FREE LOTION SPF 50 
    homosalate and octinoxate and octisalate and octocrylene and avobenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 mL  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 mL  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.05 mL  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2007-1175 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/23/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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