Drug Labeling and Warnings

Drug Details

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BANANA BOAT- titanium dioxide, zinc oxide lotion 
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

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

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)

6335492224

BANANA BOAT 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63354-922
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63354-922-24177 g in 1 TUBE; Type 0: Not a Combination Product01/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2018
Labeler - Edgewell Personal Care Brands LLC (151179769)
Establishment
NameAddressID/FEIBusiness Operations
Playtex Manufacturing Inc963501502manufacture(63354-922)

Revised: 12/2017
 
Edgewell Personal Care Brands LLC


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