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Name:Banana Boat Baby Tear Free Lotion Spf 50
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Baby Tear Free Spray Lotion SPF 50

BANANA BOAT BABY TEAR FREE LOTION SPF 50 - homosalate, octinoxate, octisalate, octocrylene and avobenzone spray 
Accra-Pac, Inc.

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.

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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

PRINCIPAL DISPLAY PANEL
Banana Boat Baby Tear Free Spray Lotion SPF 50


BANANA BOAT BABY TEAR FREE LOTION SPF 50 
homosalate and octinoxate and octisalate and octocrylene and avobenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.1 mL  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 mL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.05 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.05 mL  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2006-1 180 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 07/23/2009

Labeler - Accra-Pac, Inc. (024213616)
Establishment
Name Address ID/FEI Operations
Accra-Pac, Inc. 024213616 MANUFACTURE

Revised: 03/2010 Accra-Pac, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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