BANANA BOAT KIDS ULTRAMIST TEAR FREE SPF 30 (AVOBENZONE AND HOMOSALATE AND OCTISALATE AND OCTOCRYLENE) SPRAY [ACCRA-PAC, INC.]

BANANA BOAT KIDS ULTRAMIST TEAR FREE SPF 30 (AVOBENZONE AND HOMOSALATE AND OCTISALATE AND OCTOCRYLENE) SPRAY [ACCRA-PAC, INC.]
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NDC 17630-2011-1
Set ID 89d05291-4ee5-48c6-be1d-7ac30f323bcb
Category HUMAN OTC DRUG LABEL
Packager Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 0.03g / 1g

    Homosalate 0.15g / 1g

    Octisalate 0.05g / 1g

    Octocrylene 0.025g / 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

    Water, Isobutane, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Adipate, Polyglyceryl-3 Polyricinoleate, Glucose, PEG-8, Retinyl Palmitate (Vitamin A), Tocopherol, Sodium Ascorbyl Phosphate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate (Vitamin E), Caprylyl Glycol, Glycerin, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Sodium Citrate, Glucose Oxidase, Lactoperoxidase, Sodium Chloride, Disodium EDTA

  • Questions or Comments?

    Call 1-800 SafeSun, Mon-Fri

    Dist. by: SUN PHARMACEUTICALS CORP.
    P.O. BOX 7869, DELRAY BEACH, FL 33482
    www.bananaboat.com

  • PRINCIPAL DISPLAY PANEL

    LOTION
    ULTRAMIST
    ®
    BANANA

    BOAT
    ®
    KIDS

    TEAR FREE
    ®
    Continuous Spray Sunscreen

    SPF/UVB 30

    PEDIATRICIAN TESTED

    AvoTriplexTM
    UVA Protection

    3-Way
    ProtectionTM
    Sun-Tested, Sun-
    ProvenTM
    No Tearing – Alcohol Free

    Very Water Resistant

    NET WT. 6 OZ. (170g)

    PRINCIPAL DISPLAY PANEL
Banana Boat Kids UltraMist Tear Free SPF 30

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT KIDS ULTRAMIST TEAR FREE SPF 30 
    avobenzone and homosalate and octisalate and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2011
    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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOBUTANE (UNII: BXR49TP611)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2011-1170 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/18/2008
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE

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