Label: BANANA BOAT KIDS TEAR FREE SUNSCREEN SPF 60- homosalate and octinoxate and octisalate and avobenzone and octocrylene 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 18, 2010

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients

    Homosalate 0.15mL / 1mL

    Octinoxate 0.075mL / 1mL

    Octisalate 0.05mL / 1mL

    Avobenzone 0.03mL / 1mL

    Octocrylene 0.024mL / 1mL

  • Purpose

    Sunscreen

  • Directions:

    Apply liberally 15 to 30 minutes before sun exposure. Do not spray directly into face. Spray on hands to apply to face. Rub into skin. Reapply as needed or after swimming, towel drying, perspiring heavily, washing or vigorous activity.

  • Caution:

    For external use only. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Consult a doctor before using on children under 6 months. Use in well-ventilated area. May stain certain surfaces and fabrics. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50ºC.

  • Mode d’emploi :

    Appliquer généreusement de 15 à 30 minutes avant l’exposition au soleil. Ne pas vaporiser directement sur le visage. Vaporiser d’abord le produit dans les mains, puis appliquer sur le visage. Faire pénétrer dans la peau en frottant. Réappliquer au besoin ou après une baignade, une forte transpiration, une activité vigoureuse, s’être séché à la serviette ou s’être lavé.

  • Mise en garde :

    Pour usage externe seulement. Cesser l’emploi du produit si une irritation cutanée apparaît ou si elle s’aggrave. Si l’irritation persiste, consulter un médecin. Éviter tout contact avec les yeux. En cas de contact, rincer abondamment avec de l’eau. Garder hors de la portée des enfants. Consulter un médecin avant d’utiliser pour un enfant de moins de six mois. Utiliser dans un endroit bien aéré. Ce produit peut abîmer certaines surfaces et certains tissus. Contenu sous pression. Ne pas placer dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant ni le jeter au feu, ni le conserver à des températures dépassant 50 °C.

  • Medicinal Ingredients (% w/w)/Ingrédients médicinaux (% p/p):

    Homosalate 15.0%, Octinoxate 7.5%, Octisalate 5.0%, Avobenzone 3.0%, Octocrylene/Octocrylène 2.4%.

  • Non-medicinal Ingredients/Ingrédients non médicinaux:

    Aqua, Isohexadecane, Cetyl Dimethicone Copolyol, Caprylic/Capric Triglycerides, Stearalkonium Hectorite, Propylene Carbonate, PEG-8, Caprylyl Glycol, Sodium Chloride, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Glycerin, Sodium Citrate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, C30-38 Olefin/Isopropoyl Maleate/MA Copolymer.

  • QUESTIONS/IDÉES

    1-888-SUN-TIPS

    DISTRIBUTED BY/DISTRIBUÉ PAR:
    ENERGIZER CANADA INC.,
    WALKERTON, ON N0G 2V0
    Made in U.S.A./Fabriqué aux États-Unis
    © 2009 Sun Pharmaceuticals, LLC

  • PRINCIPAL DISPLAY PANEL

    Alcohol-Free
    Sans     alcool
    Ultra     MistTM
    New! Nouveau!
    Banana     BoatTM
    Kids
    Tear Free Sans     Iarmes
    Sunscreen Spray
    Écran solaire en vaporisateur pour enfants
    SPF/FPS 60
    Broad Spectrum Écran à large spectre
    UVA/UVB Protection
    Goes on white Lotion blanche à l’application
    Waterproof     Hydrofuge
    180 ml

    PRINCIPAL DISPLAY PANEL Banana Boat Kids Tear-Free Sunscreen Spray SPF 60

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT KIDS TEAR FREE SUNSCREEN SPF 60 
    homosalate and octinoxate and octisalate and avobenzone and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.15 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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.024 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2002-1180 mL 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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