BANANA BOAT BABY TEAR FREE LOTION SPF 50 (HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND AVOBENZONE) SPRAY [ACCRA-PAC, INC.]

BANANA BOAT BABY TEAR FREE LOTION SPF 50 (HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND AVOBENZONE) SPRAY [ACCRA-PAC, INC.]
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NDC 17630-2006-1
Set ID bcebfcd8-e4f0-482e-abb7-4e7ca3cfa0b9
Category HUMAN OTC DRUG LABEL
Packager Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENTS:

    Homosalate 0.1 mL / 1mL

    Octinoxate 0.075 mL / 1mL

    Octisalate 0.05 mL / 1mL

    Octocrylene 0.05 mL / 1mL

    Avobenzone 0.03 mL / 1mL

  • DIRECTIONS:

    Shake well before use. Apply generously and evenly to all areas 20 minutes before sun exposure. Do not spray directly on face. Spray on hands to apply to face. Reapply at frequent intervals, after swimming, towel drying and perspiring. For external use only. Avoid contact with eyes and fabrics.

  • 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 sun protection (higher than 25) is important for babies/young children. Over-exposure to the sun is a serious health threat.

  • 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, Tocopheryl Acetate, Sodium Citrate, Retinyl Palmitate, 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

    Banana
    Boat
    ®
    Baby

    Tear Free

    BROAD SPECTRUCM UVA/UVB

    SUN PROTECTION SPRAY LOTION

    SPF 50 UVA

    AvoTriplexTM
    High Protection

    Sun-Tested, Sun-
    ProvenTM
    Hypoallergenic

    Clinically Tested

    Water Resistant

    180 ml

    PRINCIPAL DISPLAY PANEL
Banana Boat Baby Tear Free Spray Lotion SPF 50

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT BABY TEAR FREE LOTION SPF 50 
    homosalate and octinoxate and octisalate and octocrylene and avobenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2006
    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)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2006-1180 mL in 1 BOTTLE
    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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