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


Drug Facts

BANANA BOAT  - octinoxate and padimate o 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

Octinoxate 2%

Padimate O 1.4%

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

Inactive Ingredients

Mineral Oil, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Musa Sapientum (Banana) Fruit Extract, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Daucus Carota Sativa (Carrot) Root Extract, Phenoxyethanol, Methylparaben, Isopropylparaben, Isobutylparaben, Butylparaben, Fragrance.

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Principal Display Panel

Banana Boat®

deep

TANNING OIL

SPF 4
UVB

Infused with Carrot and Banana Extracts
For Deep, Long-Lasting Color
Very Water Resistant

8 FL. OZ. (236ml)
Banana Boat deep Tanning Oil SPF 4 UVB 8 Fluid Oz
Banana Boat deep Tanning Oil SPF 4 UVB 8 FL OZ Drug Facts

BANANA BOAT 
octinoxate, padimate o oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-031
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2 g  in 100 g
PADIMATE O (PADIMATE O) PADIMATE O 1.4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
ALOE VERA LEAF  
COCONUT OIL  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CARROT  
PHENOXYETHANOL  
METHYLPARABEN  
ISOPROPYLPARABEN  
ISOBUTYLPARABEN  
BUTYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63354-031-16 201 g in 1 BOTTLE 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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