BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene spray

Banana Boat by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 6%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

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.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Keep away from face to avoid breathing it. 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 Children under 6 months: Ask a doctor

Inactive Ingredients

Water, Isobutane, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Myrica Cerifera (Bayberry) Fruit Wax, Ethylhexyl Methoxycrylene, Sodium Chloride, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Citrate.

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

simply

protect

baby

sunscreen spray

50+

25% fewer ingredients*

made without oxybenzone & parabens

no added oils & fragrances

broad spectrum SPF 50+

water resistant (80 minutes)

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-923
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ISOBUTANE (UNII: BXR49TP611)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOHEXADECANE (UNII: 918X1OUF1E)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-923-34	170 g in 1 CAN; 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)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Custom Product		243547333	manufacture(63354-923)