Label: BANANA BOAT ULTRA DEFENSE SPF 30 CANADA- homosalate and octinoxate and octisalate and oxybenzone 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 28, 2010

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients

    Homosalate 0.0878mL / 1mL

    Octinoxate 0.05mL / 1mL

    Octisalate 0.05mL / 1mL

    Oxybenzone 0.05mL / 1mL

    Avobenzone 0.03mL / 1mL

    Octocrylene 0.025mL / 1mL

  • 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. May stain certain surfaces and fabrics. Use in well-ventilated area. Do not use in presence of open flame or spark. 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. Ne pas utiliser en présence d’une flamme nue ou d’étincelles. Contenu sous pression. Ne pas mettre 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 8.78%, Octinoxate 5.0%, Octisalate 5.0%, Oxybenzone 5.0%, Avobenzone 3.0%, Octocrylene/Octocrylène 2.5%.

  • Non-medicinal Ingredients/Ingrédients non médicinaux:

    Alcohol Denat., C12-15 Alkyl Benzoate, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Parfum.

  • QUESTIONS/IDÉES

    1-888-SUN-TIPS

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

  • PRINCIPAL DISPLAY PANEL

    UltraMistTM
    BANANA
    BOAT    TM
    Ultra
    DefenseTM
    Spray Sunscreen
    Écran solaire en vaporisateur
    SPF/FPS 30 Aloe Vera     Aloès
    Broad Spectrum     Écran à large spectre
    UVA/UVB Protection
    Protects against drying effects of the sun
    Protège contre les effets desséchants du soleil
    180     mL

    PRINCIPAL DISPLAY PANEL Banana Boat Ultra Defense SPF 30 Canada

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT ULTRA DEFENSE SPF 30 CANADA 
    homosalate and octinoxate and octisalate and oxybenzone and avobenzone and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.0878 mL  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 mL  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.05 mL  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.025 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2041-1180 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/02/2010
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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