EAD- avobenzone, homosalate, octisalate and octocrylene lotion
European Perfume Works Co.L.L.C.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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EAD

Active Ingredients

Avobenzone 1.2%

Homosalate 2.0%

Octisalate 5.0%

Octocrylene 1.0%

Purpose

Sunscreen

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

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

amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,

carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl

stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,

propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium

EDTA, tocopheryl acetate, water.

Other Information

protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-844-875-4176

USA Distributor

ARION PERFUME & BEAUTY INC,

6417 TRI COUNTY PKWY, SUITE 100,

SCHERTZ, TEXAS-78154, U.S.A.

Packaging

EAD SPF-15

EAD
avobenzone,homosalate,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:63049-101
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1.44 g in 120 mL
HOMOSALATE (HOMOSALATE)	HOMOSALATE	2.40 g in 120 mL
OCTISALATE (OCTISALATE)	OCTISALATE	6.00 g in 120 mL
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	1.20 g in 120 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-AMYLCINNAMALDEHYDE
ASCORBYL PALMITATE
BENZYL ALCOHOL
BUTYLPARABEN
C12-15 ALKYL BENZOATE
CARBOMER 934
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
ETHYLPARABEN
GLYCERYL MONOSTEARATE
GLYCERYL STEARATE SE
ISOBUTYLPARABEN
LINALOOL, (+/-)-
METHYLPARABEN
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
SODIUM CETOSTEARYL SULFATE
EDETATE SODIUM
ALPHA-TOCOPHEROL ACETATE
WATER

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63049-101-23	120 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/18/2014

Labeler - European Perfume Works Co.L.L.C. (559250361)

Name	Address	ID/FEI	Business Operations
Establishment
European Perfume Works Co.L.L.C.		559250361	manufacture(63049-101)

Revised: 4/2014

Document Id: a13af0f0-7590-4d62-a3e0-fbedd70434ac

Set id: 277c4c8c-f771-4e33-83a5-2aa773cf49af

Version: 2

Effective Time: 20140422

European Perfume Works Co.L.L.C.