Banana Boat Baby Tear Free Lotion SPF 50

Dosage form: spray
Ingredients: HOMOSALATE 0.1mL in 1mL, OCTINOXATE 0.075mL in 1mL, OCTISALATE 0.05mL in 1mL, OCTOCRYLENE 0.05mL in 1mL, AVOBENZONE 0.03mL in 1mL
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2006

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 Spray Lotion SPF 50

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE0.1 mL  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE0.075 mL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE0.05 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.05 mL  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BEMOTRIZINOL 
CAPRYLYL GLYCOL 
MEDIUM-CHAIN TRIGLYCERIDES 
PROPYLENE CARBONATE 
GLYCERIN 
SODIUM CHLORIDE 
EDETATE DISODIUM 
GLUCOSE OXIDASE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
SODIUM CITRATE 
VITAMIN A PALMITATE 
SODIUM ASCORBYL PHOSPHATE 
ALOE VERA LEAF 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
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/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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