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Name:Banana Boat
Manufacturer:Energizer Personal Care Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BANANA BOAT  - avobenzone, octocrylene and oxybenzone oil 
Energizer Personal Care LLC

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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Drug Facts

Active Ingredients


Avobenzone 0.5%
Octocrylene 1%
Oxybenzone 0.5%

Purpose

Sunscreen

Use


helps prevent sunburn

Warnings

For external use only.

When using this product

do not get into eyes. If contact occurs, rinse throughly with water.

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
  • 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

Water, Diisopropyl Adipate, Mineral Oil, Petrolatum, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, PEG-8 Dimethicone, Ascorbic acid (Vitamin C), Retinyl Palmitate (Vatamin A), Tocopheryl Acetate (Vitamin E), Theobroma Cacao (Cocoa) Seed Butter, Musa Sapientum (Banana) Fruit Extract, Camellia Sinensis ( Green Tea) Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Butyrospermum Parkii (Shea Butter), Cocos Nucifera (Coconut) Oil, Cetyl Alcohol, VP/Eicosene Copolymer, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Fragrance, Methylparaben, Propylparaben, Benzyl Alcohol

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Principal Display Panel

Banana Boat®

deep

TANNING
With green tea

Broad Spectrum Sunscreen

SPF 4
UVB

AvotriplexTM
3- Way ProtectionTM
Sun-Tested, Sun-ProvenTM

Enriched with Antioxidants
Absorbs Quickly
Very Water Resistant

8 FL. OZ. (236 ml)
Banana Boat deep Tanning with Green tea 8 Fl oz

BANANA BOAT 
avobenzone, octocrylene, oxybenzone oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-026
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
DIISOPROPYL ADIPATE  
MINERAL OIL  
PETROLATUM  
PROPYLENE GLYCOL  
PHENOXYETHANOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
CAPRYLYL GLYCOL  
ALOE VERA LEAF  
ASCORBIC ACID  
VITAMIN A PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
GREEN TEA LEAF  
CARROT  
SHEA BUTTER  
COCONUT OIL  
CETYL ALCOHOL  
TROLAMINE  
EDETATE DISODIUM  
METHYLPARABEN  
PROPYLPARABEN  
BENZYL ALCOHOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63354-026-26 237 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/28/2010

Labeler - Energizer Personal Care LLC (021718141)
Establishment
Name Address ID/FEI Operations
Playtex Manufacturing Inc. 963501502 manufacture

Revised: 09/2010 Energizer Personal Care LLC



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


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