BANANA BOAT- octinoxate, padimate o oil 
Edgewell Personal Care Brands 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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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

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 Oil

SPRAY SUNSCREEN

4

SPF 4

Blended with carrot and Banana Extracts

FOR DEEP, LONG-LASTING COLOR

WATER RESISTANT (80 MINUTES)

SWIM . SPLASH . SPORT

6335403116

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)

Revised: 6/2017
Document Id: 53065e58-d620-3143-e054-00144ff88e88
Set id: 686a934d-2810-4ed1-97c3-b7cf4b1c92d4
Version: 4
Effective Time: 20170628
 
Edgewell Personal Care Brands LLC