Easydew Daily Water Proof Sun by DN Company Co., Ltd. / Cosmax, Inc.

Easydew Daily Water Proof Sun by

Drug Labeling and Warnings

Easydew Daily Water Proof 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 WATER PROOF SUN- zinc oxide, octinoxate, titanium dioxide, octisalate, octocrylene 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: Zinc Oxide 7.8%, Ethylhexyl Methoxycinnamate 7.0%, Titanium Dioxide 4.5%, Ethylhexyl Salicylate 4.5%, Octocrylene 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl Benzoate, Glycerin, Sodium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Methyl Methacrylate Crosspolymer, Sorbitan Isostearate, Aluminum Hydroxide, Stearic Acid, Disteardimonium Hectorite, Phenoxyethanol, Fragrance(Parfum), Silica Dimethyl Silylate, Caprylyl Glycol, Dimethicone, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Butylene Glycol, Aloe Barbadensis Leaf Extract, Citrus Aurantium Dulcis (Orange) Oil, Punica Granatum Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Vanilla Tahitensis Fruit Extract, Sodium Benzoate, Citrulline, Potassium Sorbate, Citrus Aurantifolia (Lime) Fruit Extract, Pyrus Malus (Apple) Flower Extract, Prunus Domestica Seed Extract, Prunus Persica (Peach) Flower Extract

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 easily exposed areas such as face, neck , arms and legs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY WATER PROOF SUN 
zinc oxide, octinoxate, titanium dioxide, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.6 g  in 60 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.7 g  in 60 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.7 g  in 60 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	4.2 g  in 60 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.2 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-170-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-170-01	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(60565-170)

Revised: 12/2019

Document Id: a8d469ea-660d-45a4-bd0e-2a6e5ce92162

34390-5

Set id: 3d83aa78-e7d8-4966-8dd7-c8cb3c342ccd

Version: 3

Effective Time: 20191231

 

DN Company Co., Ltd.