EAD- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Arion Perfume & Beauty, Inc.

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.

----------

EAD

Active Ingredients

Avobenzone 2.0%

Homosalate 12.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 2.0%

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 (Mon-Fri 9AM-5PM CST)

USA Distributor

ARION PERFUME & BEAUTY INC,

SAN ANTONIO, TX - 78212
U.S.A.

Manufactured by

EUROPEAN PERFUME WORKS CO.LLC

P.O Box 23121, Sharjah, United Arab Emirates

Packaging

EAD SPF 45

EAD
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70197-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.40 g in 120 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14.40 g in 120 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	6.00 g in 120 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.40 g in 120 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.40 g in 120 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70197-103-23	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/29/2015	05/30/2018
2	NDC:70197-103-25	95 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2015	05/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/29/2015	05/30/2018

Labeler - Arion Perfume & Beauty, Inc. (122258549)

Name	Address	ID/FEI	Business Operations
Establishment
EUROPEAN PERFUME WORKS CO. LLC		864294207	manufacture(70197-103)

Revised: 4/2022

Document Id: 9980aaa6-65cb-4065-ad01-8dfd7f3c939a

Set id: 464a9325-9ce5-4706-8434-1eb1de43a88d

Version: 8

Effective Time: 20220418

Arion Perfume & Beauty, Inc.