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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 2%
Oxybenzone 1.5%

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, Propylene Glycol,Petrolatum, Polyglyceryl-3 Methylglucose Distearate, Caprylyl Glycol, Cetyl Alcohol, Glyceryl Stearate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, PEG-100 Stearate, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Cocos Nucifera (Coconut) Oil, Disodium EDTA, Musa Sapientum (Banana) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Glycine Soja (Soybean) Oil, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Sorbitol, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate   Silica, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance.

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Principal Display Panel

Banana Boat®

deep

TANNING
With green tea

Broad Spectrum Sunscreen

SPF 8
UVB

with UVA

Sun-Tested, Sun-ProvenTM

Enriched with Antioxidants
Absorbs Quickly
Very Water Resistant

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

BANANA BOAT 
avobenzone, octocrylene, oxybenzone oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-027
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 2 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 1.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
DIISOPROPYL ADIPATE  
MINERAL OIL  
PROPYLENE GLYCOL  
PETROLATUM  
CAPRYLYL GLYCOL  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
TROLAMINE  
POLYOXYL 100 STEARATE  
BENZYL ALCOHOL  
SHEA BUTTER  
COCONUT OIL  
EDETATE DISODIUM  
ALOE VERA LEAF  
GREEN TEA LEAF  
CARROT  
SOYBEAN OIL  
OCTYLDODECANOL  
VITAMIN A PALMITATE  
SILICON DIOXIDE  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
SORBITOL  
ASCORBIC ACID  
PHENOXYETHANOL  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63354-027-26 237 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 11/30/2010

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

Revised: 11/2010 Energizer Personal Care LLC



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


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