Easydew Daily Ultra Shield Sun by DN Company Co.,Ltd. / Cosmax, Inc.

Easydew Daily Ultra Shield Sun by

Drug Labeling and Warnings

Easydew Daily Ultra Shield Sun 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]

EASYDEW DAILY ULTRA SHIELD SUN- homosalate, avobenzone, ensulizole cream 
DN Company Co.,Ltd.

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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ACTIVE INGREDIENT

Active Ingredient: 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

Use: 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY ULTRA SHIELD SUN 
homosalate, avobenzone, ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	6.0 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.1 g  in 60 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.1 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-160-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-160-01	60 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	07/15/2016	11/01/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-160)

Revised: 12/2019

Document Id: bd446f41-40df-4c99-b97a-178847823867

34390-5

Set id: cf49034a-c43c-4c2c-b0c0-7aef5691bd67

Version: 4

Effective Time: 20191231

 

DN Company Co.,Ltd.