BANANA BOAT ULTRAMIST BABY TEAR FREE CONTINUOUS SPF 50- avobenzone and homosalate and octinoxate and octisalate and octocrylene 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.

----------

Banana Boat UltraMist Baby Tear Free Continuous Spray SPF 50

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

When using this product

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

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.

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

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

PRINCIPAL DISPLAY PANEL

Lotion
UltraMist®
Banana Boat®
Baby
Tear Free®
Continuous Spray Sunscreen
SPF/UVB 50
AvoTriplexTM
UVA Protection
3-Way Protection
Sun-TestedTM, Sun-ProvenTM
No Tearing – Alcohol Free
Very Water Resistant
NET WT. 6 OZ. (170 g)

PRINCIPAL DISPLAY PANEL
Banana Boat UltraMist Baby Tear Free Continuous Spray SPF 50

BANANA BOAT ULTRAMIST BABY TEAR FREE CONTINUOUS SPF 50 
avobenzone and homosalate and octinoxate and octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.15 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17630-2003-1170 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/22/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIBusiness Operations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 3/2010
Document Id: 0086e81b-d038-47fa-9d83-782fc54a7c06
Set id: 6d0a8efb-4da9-4cb5-b1d3-c9dad05fa9a6
Version: 1
Effective Time: 20100318
 
Accra-Pac, Inc.