EASYDEW EG SUN ULTRA SHIELD- homosalate, avobenzone, ensulizole cream

Easydew EG SUN Ultra Shield by

Drug Labeling and Warnings

Easydew EG SUN Ultra Shield by is a Otc medication manufactured, distributed, or labeled by DN Company Co.,Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Homosalate 10.0%, Butyl Methoxydibenzoylmethane 3.5%, Phenylbenzimidazole Sulfonic Acid 3.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butyloctyl Salicylate, Butylene Glycol, Ethylhexyl Methoxycrylene, Dicaprylyl Carbonate, Dipropylene Glycol, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetearyl Alcohol, Aminomethyl Propanol, Cyclohexasiloxane, Caprylyl Methicone, Pentylene Glycol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triceteareth-4 Phosphate, Glycol Stearate, Methyl Methacrylate Crosspolymer, Silica, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Phenoxyethanol, Fragrance(Parfum), Caprylyl Glycol, Xanthan Gum, Caprylic/Capric Triglyceride, Alcohol, Disodium EDTA, 1,2-Hexanediol, Hydrogenated Lecithin, Propylene Glycol, Hydrogenated Phosphatidylcholine, Alcohol Denat., Sodium Stearoyl Glutamate, Ceramide 3, Cholesterol, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Pinus Pumilio Bark Extract, Poterium Officinale Root Extract, Veronica Officinalis Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

Help 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.

DESCRIPTION

Uses:

Help 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.

Directions:

At the last stage of your skincare routine, evenly apply onto face.

Use a suitable amount of hair treatment according to the number of hair.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EASYDEW EG SUN ULTRA SHIELD 
homosalate, avobenzone, ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.00 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.75 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-280-02	1 in 1 CARTON	06/01/2018
1	NDC: 60565-280-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Labeler - DN Company Co.,Ltd. (688369859)

Registrant - DN Company Co.,Ltd. (688369859)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-280)