BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene stick

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 Ingredients

AVOBENZONE 2.7%
HOMOSALATE 9%
OCTISALATE 4.5%
OCTOCRYLENE 9%

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 damaged or broken 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.

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

Ozokerite, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG-8, Caprylyl Glycol, Silica, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer.

Other Information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800 SafeSun, Mon-Fri

PRINCIPAL DISPLAY PANEL

NEW

LOOK!

50+

25%

FEWER

INGREDIENTS*

MADE WITHOUT OXYBENZONE

& PARABENS

BANANA

BOAT®

simply

protect™

baby

SUNSCREEN STICK

UVA/UVB BROAD SPECTRUM SPF 50+

No Added

Oils &

Fragrances

0.5 OZ.

(14.2 g)

BANANA

BOAT

Simply

Protect

SUNSCREEN STICK

baby

50+

BROAD SPECTRUM SPF 50+

WATER RESISTANT (80 MINUTES)

25% fewer ingredients*

MADE WITHOUT

OXYBENZONE & PARABENS

NO ADDED OILS

OR FRAGRANCES

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-389
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
COCOA BUTTER (UNII: 512OYT1CRR)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
CERESIN (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-389-61	14.2 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2018

Labeler - Edgewell Personal Care Brands LLC (151179769)