MOONFLASH CUSHION- octinoxate, titanium dioxide, zinc oxide, octisalate powder

Moonflash Cushion by

Drug Labeling and Warnings

Moonflash Cushion 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: 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

INGREDIENTS AND APPEARANCE

MOONFLASH CUSHION 
octinoxate, titanium dioxide, zinc oxide, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71786-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.84 g  in 12 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.71 g  in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.58 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.54 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Diisostearyl Malate (UNII: QBS8A3XZGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71786-050-02	1 in 1 CARTON	10/01/2017
1	NDC: 71786-050-01	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(71786-050)