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Banana Boat Baby Tear Free Sunscreen SPF 60

Dosage form: spray
Ingredients: HOMOSALATE 0.15mL in 1mL, OCTINOXATE 0.075mL in 1mL, OCTISALATE 0.05mL in 1mL, AVOBENZONE 0.03mL in 1mL, OCTOCRYLENE 0.024mL in 1mL
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2001

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.

Banana Boat Baby Tear Free Sunscreen Spray SPF 60

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 temperature above 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 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 supérieures à 50 ºC.

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
UltraMist TM  
New! Nouveau!

Banana Boat
 TM
Baby
Tear Free

Sans
Iarmes
Sunscreen Spray

Écran solaire en vaporisateur pour bébés 
SPF/FPS 60

Broad Spectrum
Écran à large spectre
UVA/UVB Protection

Goes on white Lotion blanche à l’application
Waterproof
Hydrofuge

 

BANANA BOAT BABY TEAR FREE SUNSCREEN SPF 60 
homosalate and octinoxate and octisalate and avobenzone and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE0.15 mL  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE0.075 mL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE0.05 mL  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.024 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
PROPYLENE CARBONATE 
CAPRYLYL GLYCOL 
SODIUM CHLORIDE 
PHENOXYETHANOL 
METHYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
ISOBUTYLPARABEN 
GLYCERIN 
SODIUM CITRATE 
EDETATE DISODIUM 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
SODIUM ASCORBYL PHOSPHATE 
POLYETHYLENE GLYCOL 400 
Packaging
#Item CodePackage Description
1NDC:17630-2001-1180 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/FEIOperations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 03/2010
 
Accra-Pac, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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