EASYDEW EX MINERAL BB SPF45 PA PLUS PLUS- titanium dioxide, octinoxate, zinc oxide cream

Easydew EX Mineral BB by

Drug Labeling and Warnings

Easydew EX Mineral BB 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: Titanium Dioxide 9.94%, Ethylhexyl Methoxycinnamate 7%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Carbonate, Butylene Glycol, Arbutin, Sodium Chloride, Rosa Canina Fruit Oil, Avena Sativa (Oat) Kernel Extract, Amethyst Powder, Pearl Powder, Tourmaline, Brassica Oleracea Italica (Broccoli) Sprout Extract, Zea Mays (Corn) Leaf Extract, Triticum Aestivum (Wheat) Leaf Extract, Hydrolyzed Coral, Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Isoamyl p-Methoxycinnamate, Dimethicone, Glyceryl Behenate/Eicosadioate, Caprylic/Capric Glycerides, Ethylhexylglycerin, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Adenosine, Hydrogenated Lecithin, Potassium Cetyl Phosphate, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

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 MINERAL BB  SPF45 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.97 mg  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.8 mg  in 40 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.17 mg  in 40 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: 60565-040-01	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(60565-040)