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Name:Banana Boat Ultra Defense Sheer Protect Spf 50
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Ultra Defense Sheer Protect SPF 50

BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50 - avobenzone, 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

  • 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.

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2033
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.10 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.05 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAPRYLYL GLYCOL  
ALOE VERA LEAF  
VITAMIN A PALMITATE  
ASCORBIC ACID  
.ALPHA.-TOCOPHEROL ACETATE, D-  
OCTYLDODECANOL  
SILICON DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2033-1 177 mL in 1 CAN None
2 NDC:17630-2033-2 236 mL in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 09/15/2009

Labeler - Accra-Pac, Inc. (024213616)
Establishment
Name Address ID/FEI Operations
Accra-Pac, Inc. 024213616 MANUFACTURE

Revised: 03/2010 Accra-Pac, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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