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, Playtex Manufacturing Inc. 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

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.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Keep away from face to avoid breathing it. 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

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.

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

simply

protect

baby

mineral based sunscreen lotion

50+

25% fewer ingredients*

made without oxybenzone & parabens

no added oils & fragrances

broad spectrum spf 50+

water resistant (80 minutes)

BANANA

BOAT®

NEW

LOOK!

simply

protect™

baby

MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

tear free

No Added Oils & Fragrances

Water Resistant

(80 Minutes)

6 FL/ OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-922
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
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOHEXADECANE (UNII: 918X1OUF1E)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-922-24	177 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2018

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc		963501502	manufacture(63354-922)