BANANA BOAT- titanium dioxide, zinc oxide lotion

Banana Boat by

Drug Labeling and Warnings

Banana Boat by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

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 minutes before sun exposure

Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Children under 6 months: Ask a doctor

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane,Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone,Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

Front Label

Tear-free Sting-free

BANANA BOAT

KIDS

UVA/UVB PROTECTION

SUNCREEN LOTION

50

BROAD SPECTRUM

SPF 50

Mineral Based Protection

No Added Fragrance

Water Resistant

(80 MINUTES)

SWIM SPLASH SPORT

INGREDIENTS AND APPEARANCE

BANANA BOAT 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-328-21	59 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2017
2	NDC: 63354-328-26	236 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2017
3	NDC: 63354-328-27	295 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2017
4	NDC: 63354-328-38	354 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - Edgewell Personal Care Brands LLC (151179769)