BANANA BOAT- octinoxate, padimate o oil

BANANA BOAT by

Drug Labeling and Warnings

BANANA BOAT by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands, LLC, Playtex Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 2.0%

Padimate O 1.4%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

For external use only

Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a poison control center right away.

May stain some fabrics

Directions

• apply liberally 15 mins before sun exposure
• Do not spray directly into face. Spray on hands then apply to face.
• Reapply: after 80 mins of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: Ask a doctor

Inactive ingredients

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

Other Information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

Principal display panel

BANANA BOAT®

DEEP TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 4

4

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL.OZ. (236 mL)

BANANA

BOAT

deep

Tanning Oil

SPRAY SUNSCREEN

4

SPF 4

Blended with carrot and Banana Extracts

FOR DEEP, LONG-LASTING COLOR

WATER RESISTANT (80 MINUTES)

SWIM . SPLASH . SPORT

INGREDIENTS AND APPEARANCE

BANANA BOAT 
octinoxate, padimate o oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	1.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
COCOA BUTTER (UNII: 512OYT1CRR)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
CORN OIL (UNII: 8470G57WFM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BANANA (UNII: 4AJZ4765R9)
CARROT (UNII: L56Z1JK48B)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-031-16	201 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2010

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

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc		963501502	manufacture(63354-031)