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Name:Banana Boat Protective Dry Spf 15
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Protective Dry Oil SPF 15

BANANA BOAT PROTECTIVE DRY SPF 15 - avobenzone, octocrylene and oxybenzone oil 
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 Protective Dry Oil SPF 15

Drug Facts

Active Ingredients

Avobenzone 0.03mL / 1mL

Octocrylene  0.05mL / 1mL

Oxybenzone 0.03mL / 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, Mineral Oil, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/ Tricaprate, Ethylhexyl Benzoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Cetearyl Ethylhexanoate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Aloe Barbadensis Leaf Extract, Fragrance

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

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

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA

BOAT
®
protective

TANNING

DRY OIL

Continuous Spray Sunscreen

SPF/UVB 15

AvoTriplexTM
High UVA

3-Way
ProtectionTM
Sun-Tested, Sun-
ProvenTM
Fast & Even Coverage

Coconut & Grape Seed Oils

Very Water Resistant

6 FL. OZ. (177
mL)

PRINCIPAL DISPLAY PANEL
Banana Boat Protective Dry Oil SPF 15


BANANA BOAT PROTECTIVE DRY SPF 15 
avobenzone and octocrylene and oxybenzone oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2017
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 0.05 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.03 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
COCONUT OIL  
GRAPE SEED OIL  
DICAPRYLYL CARBONATE  
CAPRYLYL GLYCOL  
ALPHA-TOCOPHEROL  
VITAMIN A PALMITATE  
ALOE VERA LEAF  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2017-1 177 mL in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 07/17/2008

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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