MICROFIT CUSHION 201- titanium dioxide, octinoxate, octisalate powder 
Codecosme International 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 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

Image of carton

MICROFIT CUSHION 201 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71786-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.15 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.48 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
PEG-8 Dimethicone (UNII: GIA7T764OD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71786-030-021 in 1 CARTON10/01/2017
1NDC:71786-030-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2017
Labeler - Codecosme International Co., Ltd. (689846614)
Registrant - Codecosme International Co., Ltd. (689846614)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(71786-030)

Revised: 10/2017
Document Id: 41987545-0239-4995-9f18-70877d8b7d2d
Set id: 4c2a472e-7721-41ff-9055-5a692434799c
Version: 1
Effective Time: 20171018
 
Codecosme International Co., Ltd.