Easydew Daily Fresh Mild Sun by DN Company Co.,Ltd. / Cosmax, Inc.

Easydew Daily Fresh Mild Sun by

Drug Labeling and Warnings

Easydew Daily Fresh Mild 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 FRESH MILD SUN SPF50 PLUS- homosalate, octisalate, titanium dioxide, avobenzone 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%, Ethylhexyl Salicylate 5.0%, Titanium Dioxide (CI 77891) 3.825%, Butyl Methoxydibenzoylmethane 3.0%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Ethylhexyl Palmitate, Cyclopentasiloxane, Butylene Glycol, Acrylates Copolymer, Cetearyl Alcohol, Dipropylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, PEG-2 Stearate, Potassium Cetyl Phosphate, Sorbitan Sesquioleate, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Caprylyl Glycol, Fragrance(Parfum), Glyceryl Caprylate, Dimethicone, Caprylic/Capric Triglyceride, Alcohol, Xanthan Gum, Disodium EDTA, Hydrogenated Phosphatidylcholine, Propylene Glycol, 1,2-Hexanediol, Hydrogenated Lecithin, Ceramide NP, Cholesterol, Pinus Pumilio Bark Extract, Sodium Stearoyl Glutamate, Poterium Officinale Root Extract, Veronica Officinalis Extract, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only.

Keep out of reach of children.

Avoid contact with eyes.

If eye contact occurs, rinse immediately with water and if it is necessary, contact an ophthalmologist. Discontinue use if signs of irritation and/or rash appear.

Keep in a cool and dry place.

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 FRESH MILD SUN  SPF50 PLUS
homosalate, octisalate, titanium dioxide, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60565-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate6.0 g  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate3.0 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.29 g  in 60 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone1.8 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60565-220-021 in 1 CARTON11/01/201711/01/2019
1NDC: 60565-220-0160 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 finalpart35211/01/201711/01/2019
Labeler - DN Company Co.,Ltd. (688369859)
Registrant - DN Company Co.,Ltd. (688369859)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60565-220)

Revised: 12/2019
Document Id: 494e9cef-7df0-4e23-b78c-94462162d050
Set id: be50c5a3-49c2-42b4-bd70-764ada4da291
Version: 3
Effective Time: 20191231
 
DN Company Co.,Ltd.