It Radiant CC Cover Natural Beige by F&CO Co., Ltd. / Cosmax, Inc

Drug Details [pdf]

IT RADIANT CC COVER NATURAL BEIGE- titanium dioxide, zinc oxide, octinoxate cream
F&CO 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 7.35%, Zinc Oxide 4.90%, Ethylhexyl Methoxycinnamate 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Phenyl Trimethicone, Caprylyl Methicone, Butylene Glycol, Cyclopentasiloxane, Glycerin, Methyl Trimethicone, Cyclomethicone, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, 1,2-Hexanediol, Tridecyl Trimellitate, Butylene Glycol Dicaprylate/Dicaprate, Maltitol, Polypropylsilsesquioxane, VP/Hexadecene Copolymer, Cyclohexasiloxane, Magnesium Sulfate, Disteardimonium Hectorite, Dipentaerythrityl Hexa C5-9 Acid Esters, Glyceryl Tribehenate/Isostearate/Eicosandioate, Sorbitan Isostearate, Tribehenin, Aluminum Hydroxide, Iron Oxides (CI 77492), Dimethicone, Stearic Acid, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Chamomilla Recutita (Matricaria) Flower Extract, Centella Asiatica Extract, Dimethicone Crosspolymer, Ethylhexylglycerin, Glyceryl Caprylate, Fragrance(Parfum), Synthetic Fluorphlogopite, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Mica (CI 77019), Argania Spinosa Kernel Oil, Oenothera Biennis (Evening Primrose) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Caprylic/Capric Triglyceride, Sodium Hyaluronate, Hydrogenated Lecithin, Aspalathus Linearis Extract, Centaurea Cyanus Flower Water, Lilium Candidum Flower Water, Paeonia Albiflora Root Extract, Phenoxyethanol, Ceramide NP, Hibiscus Sabdariffa Flower Extract, Tilia Europaea Flower Extract, Portulaca Oleracea Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lavandula Angustifolia (Lavender) Oil

PURPOSE

PURPOSE: Sunscreen

WARNINGS

WARNINGS: If redness or irritation occurs, discontinue use, and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

INDICATION AND USAGE

INDICATION AND USAGE: After skin care, evenly spread moderate amount on skin. * Softly spreads on skin where hand touches. Doesn’t become thick or turns yellow although severely coated on skin. Everyone can easily use the product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

IT RADIANT CC COVER NATURAL BEIGE
titanium dioxide, zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-480
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.20 g in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.47 g in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.50 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69106-480-02	1 in 1 CARTON	10/01/2017	11/01/2019
1	NDC: 69106-480-01	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/01/2017	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(69106-480)

Revised: 1/2020

Document Id: eb19f319-210f-4b21-a841-9f7427cb2cdb

Set id: 6e314687-6dec-4f69-a4fc-c11af4d98676

Version: 2

Effective Time: 20200108

F&CO Co., Ltd.