EAD- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

EAD by

Drug Labeling and Warnings

EAD by is a Otc medication manufactured, distributed, or labeled by EUROPEAN PERFUME WORKS CO. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EAD 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63049-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER 934 (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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63049-103-23	120 mL in 1 TUBE; Type 0: Not a Combination Product	03/18/2014
2	NDC: 63049-103-25	95 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/18/2014

Labeler - European Perfume Works Co. L.L.C (851151050)

Establishment
Name	Address	ID/FEI	Business Operations
European Perfume Works Co. L.L.C		851151050	manufacture(63049-103)