MICROFIT CUSHION 201- titanium dioxide, octinoxate, octisalate powder

Microfit Cushion 201 by

Drug Labeling and Warnings

Microfit Cushion 201 by is a Otc medication manufactured, distributed, or labeled by Codecosme International Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 9.66%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive ingredients: Bambusa Vulgaris Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Butylene Glycol, Glycerin, Niacinamide, Mica (CI 77019), Dimethicone, Iron Oxides (CI 77492), Silica, Cetyl PEG/PPG-10/1 Dimethicone, Dipropylene Glycol, Magnesium Sulfate, Phenoxyethanol, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diphenyl Dimethicone, Fragrance(Parfum), Water, Stearic Acid, Alumina, Disteardimonium Hectorite, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Aluminum Hydroxide, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Calcium Carbonate, Polymethylsilsesquioxane, Gossypium Herbaceum (Cotton) Powder, Caprylic/Capric Triglyceride, Lecithin, Polyglutamic Acid, Cassia Angustifolia Seed Polysaccharide, Phospholipids, Ceramide NP, 1,2-Hexanediol, Cholesterol, Arginine, Phytosterols

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. 4. For external use only.

DESCRIPTION

Uses: An ultra-light and non-oxidizing cushion foundation that allows layering without caking. Perfect for mid-day touch ups.

Directions: 1. Gently soak the applicator puff on to mesh to use product. 2. Start from inner areas of the face and work outwards 3. Softly swipe over the skin to spread evenly before applying the foundation. * Coverage can build up by layering a small amount several times. 4. Close cap after use. 5. To refill the product: Open outer cap, but close the inner cap and flip over the product. While holding the product push down on the bottom sticker with both thumbs while having outer cap open. Once the existing container is removed, replace it with a refill with the hinge set on the dipped area which is on the left hand side.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICROFIT CUSHION 201 
titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71786-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.15 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.48 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
PEG-8 Dimethicone (UNII: GIA7T764OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71786-030-02	1 in 1 CARTON	10/01/2017
1	NDC: 71786-030-01	12 g in 1 CONTAINER; 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	10/01/2017

Labeler - Codecosme International Co., Ltd. (689846614)

Registrant - Codecosme International Co., Ltd. (689846614)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71786-030)