BANANA BOAT ULTRAMIST KIDS TEAR FREE LOTION SPF 50- homosalate and octinoxate and octisalate and 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 mL  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 mL  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.05 mL  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BEMOTRIZINOL (UNII: PWZ1720CBH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17630-2007-1175 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/23/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIBusiness Operations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 3/2010
Document Id: 7902a1cb-8398-4127-8feb-3270158cabed
Set id: 03fbbb81-bd8b-488a-b013-d06203bf5c7f
Version: 1
Effective Time: 20100321
 
Accra-Pac, Inc.