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

Banana Boat Kids Tear Free Continuous SPF 50 by

Drug Labeling and Warnings

Banana Boat Kids Tear Free Continuous 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

Drug Facts

Active Ingredients

Avobenzone 0.03g / 1g

Homosalate 0.15g / 1g

Octinoxate 0.075g / 1g

Octisalate 0.05g / 1g

Octocrylene 0.024g / 1g

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

• For external use only
  
• Do not spray directly into face
  
• Flammable do not use near heat, flame, or while smoking

When using this product

• avoid spraying in eyes. If contact occurs, rinse thoroughly with water.
  
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
  
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

irritation or rash develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously and evenly to all areas 15 minutes before sun exposure
  
• spray on hands to apply to face
  
• use in well-ventilated area
  
• reapply at frequent intervals and after swimming or towel drying
  
• ask a doctor before use on children under six months of age

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

• May stain some fabrics.

Inactive Ingredients

Isobutane, Water, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Glycol, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Tocopheryl Acetate (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Sodium Citrate, Sodium Chloride, Aloe Barbadensis (Aloe Vera) Leaf Juice, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Disodium EDTA

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

www.bananaboat.com

Dist. by: SUN PHARMACEUTICALS CORP.
P.O. BOX 7869, DELRAY BEACH, FL 33482

PRINCIPAL DISPLAY PANEL

LOTION
UltraMist®
Banana Boat®
Kids
Tear Free®
Continuous Spray Sunscreen
SPF/UVB 50 Pediatrician Tested
AvoTriplexTM
UVA Protection
3-Way ProtectionTM
Sun-Tested, Sun-Proven
No Tearing – Alcohol Free
Very Water Resistant
NET WT. 6 OZ. (170 g)

INGREDIENTS AND APPEARANCE

BANANA BOAT KIDS TEAR FREE CONTINUOUS SPF 50 
avobenzone and homosalate and octinoxate and octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.15 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.024 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2004-1	170 g in 1 CAN
2	NDC: 17630-2004-2	226 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/22/2009

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE