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 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 3.1%
Zinc Oxide 4.0%

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 broken or damaged 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
• 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 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-sleeve shirts, pants, hats, and sunglasses
• 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, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol.

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

Kids

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Fragrance Free

Water Resistant (80 minutes)

Recommended

Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Sport

8 FL. OZ. (236 mL)

Banana Boat

Kids

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Fragrance Free

Water Resistant (80 minutes)

Recommended

Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Sport

2 FL. OZ. (59 mL)

Bonus 25% More

Banana Boat

Kids

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Fragrance Free

Water Resistant (80 minutes)

Recommended

Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Sport

10 FL. OZ. (295 mL)

Banana Boat

Kids

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Fragrance Free

Water Resistant (80 minutes)

Recommended

Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Sport

6 FL. OZ. (177 mL)

55% More Family Size!

Banana Boat

Kids

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Fragrance Free

Water Resistant (80 minutes)

Recommended

Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Sport

12 FL. OZ. (354 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-051
Route of Administration	TOPICAL

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: 63354-051-16	245 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2012
2	NDC: 63354-051-11	61 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2012
3	NDC: 63354-051-17	306 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2012
4	NDC: 63354-051-14	184 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2012
5	NDC: 63354-051-18	368 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/04/2012

Labeler - Edgewell Personal Care LLC (151179769)