BANANA BOAT- avobenzone homosalate octocrylene aerosol

Banana Boat by

Drug Labeling and Warnings

Banana Boat by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC, Playtex Manufacturing, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

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

Flammability: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or
store at temperatures above 120ºF. 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 and then apply to face. Do not apply in windy conditions Use in a 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 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.Children under 6 months: Ask a doctor

Inactive Ingredients

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate,Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

PDP

Clear

Ultramist

BANANA

BOAT

SPORT

PERFORMANCE

with POWERSTAY

TECHNOLOGY

continuous spray sunscreen

30

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 30

HEAVY DUTY PROTECTION

ULTRA-LIGHTWEIGHT FEEL

WATER & SWEAT RESISTANT

(80 MINUTES)

SWIM . SPLASH . SPORT

NET WT.

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone homosalate octocrylene aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MINERAL OIL (UNII: T5L8T28FGP)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-170-34	170 g in 1 CAN; Type 0: Not a Combination Product	10/01/2015
2	NDC: 63354-170-36	227 g in 1 CAN; Type 0: Not a Combination Product	10/01/2015
3	NDC: 63354-170-37	269 g in 1 CAN; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2015

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing, Inc		963501502	manufacture(63354-170)