BANANA BOAT- titanium dioxide and zinc oxide lotion 
Energizer Personal Care 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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Drug Facts

Active Ingredients

Titanium Dioxide 3.1%
Zinc Oxide 4.0%

Purpose

Sunscreen

Uses

Warnings

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 swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics.

Directions

Other information

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

8 FL. OZ. (236 mL)

Bonus 25% More

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

10 FL. OZ. (295 mL)

BB Baby SPF 50 8 oz

BB Baby SPF 50 10 oz

BANANA BOAT 
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63354-050
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63354-050-26 236 g in 1 TUBE
2 NDC:63354-050-27 295 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/03/2012
Labeler - Energizer Personal Care LLC (021718141)

Revised: 10/2012
Document Id: 4e00f3f0-eaa9-4a56-bc2b-85058ffc5812
Set id: decfb4bd-c7aa-46eb-ac08-eee56ef4390f
Version: 1
Effective Time: 20121003
 
Energizer Personal Care LLC