MOONFLASH CUSHION- octinoxate, titanium dioxide, zinc oxide, 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: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.99%, Zinc Oxide 4.91%, Ethylhexyl Salicylate 4.50%

INACTIVE INGREDIENT

Inactive ingredients: Bambusa Vulgaris Water, Diphenylsiloxy Phenyl Trimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Synthetic Fluorphlogopite, Diisostearyl Malate, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Butylene Glycol, Trimethylsiloxysilicate, Dipropylene Glycol, Mica (CI 77019), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Dimethicone, Fragrance(Parfum), Dimethicone Crosspolymer, Ultramarines (CI 77007), Tin Oxide (CI 77861), Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Biosaccharide Gum-4, Milk Lipids, Pearl Powder, Sucrose Polycottonseedate, Betula Platyphylla Japonica Juice, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Polyglutamic Acid

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: UV Protection / Whitening / Anti-wrinkle. A cushion compact with ultra light texture that can easily create a radiant complexion. Can be used as a makeup base and/or a highlighter.

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. 4. To use as a highlighter, apply on desired areas such as brow area, nose, cheekbones, forehead and top of the chin. 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

MOONFLASH CUSHION 
octinoxate, titanium dioxide, zinc oxide, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71786-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.84 g  in 12 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.71 g  in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.58 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.54 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71786-050-021 in 1 CARTON10/01/2017
1NDC:71786-050-0112 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(71786-050)

Revised: 10/2017
Document Id: fb2ee071-a928-4767-bcb3-a145e19bde1e
Set id: 17ee083d-2cc4-4e0d-8569-0072314b1a33
Version: 1
Effective Time: 20171018
 
Codecosme International Co., Ltd.