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

Banana Boat Baby Tear Free Lotion SPF 50 by

Drug Labeling and Warnings

Banana Boat Baby 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 0.1 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

INGREDIENTS AND APPEARANCE

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

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)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2006-1	180 mL in 1 BOTTLE

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