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.

----------

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

Image of cartonImage of carton

EASYDEW DAILY ULTRA SHIELD SUN 
homosalate, avobenzone, ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60565-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate6.0 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1 g  in 60 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2.1 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60565-160-021 in 1 CARTON07/15/201611/01/2019
1NDC: 60565-160-0160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/15/201611/01/2019
Labeler - DN Company Co.,Ltd. (688369859)
Registrant - DN Company Co.,Ltd. (688369859)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60565-160)

Revised: 12/2019
 
DN Company Co.,Ltd.