BANANA BOAT- avobenzone, homosalate, octocrylene, oxybenzone oil

BANANA BOAT by

Drug Labeling and Warnings

BANANA BOAT by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%
Homosalate 5.0%
Octocrylene 4.0%
Oxybenzone 3.0%

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.

Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use on damaged or broken skin.

When using this product

• keep away from face to avoid breathing it
• 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

• hold container 4 to 6 inches from the skin to apply
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• do not spray directly into face. Spray on hands then apply to face
• do not apply in windy conditions
• use in well-ventilated area
• 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

Alcohol Denat., Mineral Oil, C12-15 Alkyl Lactate, Ethylhexyl Benzoate, Trimethylolpropane Tricaprylate/Tricaprate, Acrylates/Octylacrylamide Copolymer, Cetearyl Ethylhexanoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Caprylyl Glycol, Dimethyl Capramide, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Fragrance.

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

Principle Display Panel

BANANA BOAT

protective

Dry Oil

UVA/UVB PROTECTION

CONTINUOUS SPRAY SUNSCREEN

25

BROAD SPECTRUM

SPF 25

COCONUT & GRAPE SEED OIL

FAST & EVEN COVERAGE

WATER RESISTANT (80 MINUTES)

SWIM SPLASH SPORT

6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone, homosalate, octocrylene, oxybenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
COCONUT OIL (UNII: Q9L0O73W7L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-220-34	177 g in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2012

Labeler - Edgewell Personal Care Brands LLC (151179769)