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Name:Banana Boat Sport Performance Spf 85
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Sport Performance SPF 85

BANANA BOAT SPORT PERFORMANCE SPF 85 - avobenzone, homosalate, 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 Sport Performance SPF 85

Drug Facts

Active Ingredients

Avobenzone 0.03mL / 1mL

Homosalate 0.15mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.06mL / 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, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/Tricaprate, Dicaprylyl Carbonate, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Fragrance.

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA

BOAT
®
SPORT

PerformanceTM
Active Dry Protect

Continuous Spray Sunscreen

SPF/UVB 85

AvoTriplexTM
High UVA

Long-Lasting Protection

Sun-Tested, Sun-
ProvenTM
Invisible, Rub-Free

Non-Greasy

Very Water/Sweat Resistant

6 FL. OZ. (177
mL)

PRINCIPAL DISPLAY PANEL
Banana Boat Sport Performance SPF 85


BANANA BOAT SPORT PERFORMANCE SPF 85 
avobenzone and homosalate and octocrylene and oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2014
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
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.15 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.10 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.06 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5  
CYCLOMETHICONE 6  
DICAPRYLYL CARBONATE  
CAPRYLYL GLYCOL  
ALOE VERA LEAF  
VITAMIN A PALMITATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2014-1 177 mL in 1 CAN None
2 NDC:17630-2014-2 236 mL in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 06/01/2009

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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