BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50- avobenzone and octocrylene and oxybenzone 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 Ultra Defense Sheer Protect SPF 50

Drug Facts

Active Ingredients

Avobenzone 0.03mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.05mL / 1mL

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

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.

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

SD Alcohol 40-B, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl, Thiosulfate Silica, Octyldodecanol, Silica, Fragrance.

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

MADE IN U.S.A.
Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484
© 2009 Sun Pharmaceuticals, LLC

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA

BOAT
®
Ultra

DefenseTM
Sheer Protect

Continuous Spray Sunscreen

SPF/UVB 50 with Aloe Vera

AvoTriplexTM
High UVA

Long-Lasting Protection

Sun-Tested, Sun-
ProvenTM
Lightweight & Rub-Free

Skin Cancer Foundation

Recommended

Very Water Resistant

6 FL. OZ. (177
mL)

PRINCIPAL DISPLAY PANEL
Banana Boat Ultra Defense Sheer Protect SPF 50

BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50 
avobenzone and octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.10 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.05 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17630-2033-1177 mL in 1 CAN
2NDC:17630-2033-2236 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/15/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIBusiness Operations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 3/2010
Document Id: 7edaa698-1afd-4f83-af48-2895d699c038
Set id: a84fa20b-3e1d-45de-8f6d-858738319cb2
Version: 1
Effective Time: 20100327
 
Accra-Pac, Inc.