Banana Boat (Titanium Dioxide, Zinc Oxide) Lotion [Edgewell Personal Care Brands Llc] -

BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]
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NDC	63354-924-21, 63354-924-24, 63354-924-27
Set ID	617dceab-3199-2c4c-e053-2a91aa0a6649
Category	HUMAN OTC DRUG LABEL
Packager	Edgewell Personal Care Brands LLC
Generic Name
Product Class
Product Number
Application Number	PART352

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Active Ingredients

TITANIUM DIOXIDE 4.5%
ZINC OXIDE 6.5%
Purpose

Sunscreen
Uses

Helps prevent sunburn
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

NEW!

25% MORE

VALUE SIZE

tear free

BANANA

BOAT (R)

simply

protect (TM)

KiDS

MINERAL-BASED SUNSCREEN LOTION

50+

25% fewer ingredients*

MADE WITHOUT OXYBENZONE & PARABENS

NO ADDED OILS & FRAGRANCES

BROAD SPECTRUM SPF 50+

WATER RESISTANT (80 MINUTES)

7.5 FL. OZ. (221.8 mL)

50%

MORE

FAMILY SIZE!

9 OZ VS 6 OZ

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

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)

9 FL. OZ. (270 mL)

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

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)

1 FL. OZ. (29 mL)

BANANA

BOAT®

NEW

LOOK!

simply

protect™

KiDS

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)

Tear free

Banana

Boat

simply

protect

kids

mineral based sunscreen lotion

50+

25% fewer ingredients*

made without oxybenzone & parabens

no added oils & fragrances

broad spectrum spf 50+

water resistant (80 minutes)

INGREDIENTS AND APPEARANCE

BANANA BOAT
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63354-924
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOHEXADECANE (UNII: 918X1OUF1E)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63354-924-21	29 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2018
2	NDC:63354-924-24	177 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2018
3	NDC:63354-924-27	270 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2018
4	NDC:63354-924-26	7.5 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2020

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

Labeler - Edgewell Personal Care Brands LLC (151179769)

Name	Address	ID/FEI	Business Operations
Establishment
Playtex Manufacturing Inc		963501502	manufacture(63354-924)

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Medic

BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]

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