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

  • Category: HUMAN OTC DRUG LABEL

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 18, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 0.03g / 1g

    Homosalate 0.15g / 1g

    Octinoxate 0.075g / 1g

    Octisalate 0.05g / 1g

    Octocrylene 0.024g / 1g

  • 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

    • 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.
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • 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

    • shake well before use
    • 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
  • 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

    Isobutane, Water, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Glycol, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/ Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Tocopheryl Acetate (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Sodium Citrate, Sodium Chloride, Aloe Barbadensis (Aloe Vera) Leaf Juice, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Disodium EDTA

  • Questions or Comments?

    Call 1-800 SafeSun, Mon-Fri

    Distributed by:
    SUN PHARMACEUTICALS CORP.
    P.O. BOX 7869
    DELRAY BEACH, FL 33482

  • PRINCIPAL DISPLAY PANEL

    Lotion
    UltraMist®
    Banana Boat®
    Baby
    Tear Free®
    Continuous Spray Sunscreen
    SPF/UVB 50
    AvoTriplexTM
    UVA Protection
    3-Way Protection
    Sun-TestedTM, Sun-ProvenTM
    No Tearing – Alcohol Free
    Very Water Resistant
    NET WT. 6 OZ. (170 g)

    PRINCIPAL DISPLAY PANEL Banana Boat UltraMist Baby Tear Free Continuous Spray SPF 50

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT ULTRAMIST BABY TEAR FREE CONTINUOUS SPF 50 
    avobenzone and homosalate and octinoxate and octisalate and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.15 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.024 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2003-1170 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/22/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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