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


Banana Boat UltraMist Kids Tear Free Lotion Spray SPF 50

BANANA BOAT ULTRAMIST KIDS 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 UltraMist Kids Tear Free Lotion Spray SPF 50

ACTIVE INGREDIENTS:

Homosalate 0.1mL / 1mL

Octinoxate 0.075mL / 1mL

Octisalate 0.05mL / 1mL

Octocrylene 0.05mL / 1mL

Avobenzone 0.03mL / 1mL

DIRECTIONS:

Apply generously and evenly to all areas 20 minutes before sun exposure. Do not spray on face. Spray on hands to apply to face. Use in a well-ventilated area. Reapply at frequent intervals, after swimming, perspiring and towel drying.

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 (higher than 25) sun protection is important for babies and young children. Over-exposure to the sun is a serious health threat. For external use only. Avoid contact with eyes. If irritation or rash appears, discontinue use.

WARNING:

Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Keep out of reach of children.

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, Retinyl Palmitate,Sodium Citrate, Tocopheryl Acetate, 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

LOTION
UltraMist®
Banana

Boat
®
Kids

Tear Free

ADVANCED UVA/UVB SPRAY SUN PROTECTION

SPF 50 UVA

AvoTriplex
High
ProtectionTM
Sun-Tested, Sun-
ProvenTM
Fast & Even Coverage

Continuous Lotion Spray

Water Resistant

175 ml

PRINCIPAL DISPLAY PANEL
Banana Boat UltraMist Kids Tear Free Lotion Spray SPF 50


BANANA BOAT ULTRAMIST KIDS 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:17630-2007
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  
VITAMIN A PALMITATE  
SODIUM CITRATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
SODIUM ASCORBYL PHOSPHATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2007-1 175 mL in 1 CAN 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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