EASYDEW EX FRESH MILD SUNSCREEN SPF50 PLUS PA PLUS PLUS PLUS- octinoxate, titanium dioxide, octisalate, octocrylene cream

Easydew EX Fresh Mild SunScreen by

Drug Labeling and Warnings

Easydew EX Fresh Mild SunScreen 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: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%, Octocrylene 2%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Ethylhexyl Palmitate, Cyclopentasiloxane,4-Methylbenzylidene Camphor, Butylene Glycol, Butyl Methoxydibenzoylmethane, Dipropylene Glycol, Cetearyl Alcohol, Beeswax, Glyceryl Stearate, Polysorbate 60, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Silica, Potassium Cetyl Phosphate, Methyl Methacrylate Crosspolymer, Isoamyl Laurate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Caprylate, Caprylyl Glycol, Dimethicone, Caprylic/Capric Triglyceride, Saccharide Isomerate, Hydrogenated Lecithin, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., Xanthan Gum, BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

DOSAGE AND ADMINISTRATION

Dosage and administration:
In the morning at the end of your daily skin care routine, take an appropriate amount and apply to your entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EASYDEW EX FRESH MILD SUNSCREEN  SPF50 PLUS PA PLUS PLUS PLUS
octinoxate, titanium dioxide, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3 mg  in 40 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.7 mg  in 40 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.8 mg  in 40 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.8 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-050-01	40 mL in 1 CARTON; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2013

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-050)