BANANA BOAT ULTRAMIST KIDS TEAR FREE LOTION SPF 50- homosalate and octinoxate and octisalate and octocrylene and avobenzone spray

Banana Boat UltraMist Kids Tear Free Lotion SPF 50 by

Drug Labeling and Warnings

Banana Boat UltraMist Kids Tear Free Lotion SPF 50 by is a Otc medication manufactured, distributed, or labeled by Accra-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 mL  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 mL  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.05 mL  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2007-1	175 mL in 1 CAN

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	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE