Label: BANANA BOAT BABY TEAR FREE LOTION SPF 50- homosalate and octinoxate and octisalate and octocrylene and avobenzone 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 21, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!