It Radiant CC Color Base Rose by F&CO Co., Ltd. / Cosmax, Inc

It Radiant CC Color Base Rose by

Drug Labeling and Warnings

It Radiant CC Color Base Rose by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IT RADIANT CC COLOR BASE ROSE- 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 4.28%, Zinc Oxide 4.90%, Ethylhexyl Methoxycinnamate 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, Dipropylene Glycol, PEG-10 Dimethicone, Niacinamide, Pentylene Glycol, Undecane, Tridecane, Caprylyl Methicone, Disteardimonium Hectorite, Tribehenin, Magnesium Sulfate, Phenoxyethanol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Cetearyl Dimethicone/Vinyl Dimethicone Crosspolymer, Stearic Acid, Iron Oxides (CI 77491), Dimethicone, Ethylhexylglycerin, Triethoxycaprylylsilane, Adenosine, Fragrance(Parfum), Synthetic Fluorphlogopite, Disodium EDTA, Iron Oxides (CI 77492), Mica (CI 77019), Trehalose, Methyl Methacrylate Crosspolymer, Butylene Glycol, Tocopherol, Silica, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hyaluronate, Rosa Damascena Flower Oil, Rosa Gallica Flower Extract, Centella Asiatica Extract, Malpighia Emarginata (Acerola) Fruit Extract, Prunus Serrulata Flower Extract, Portulaca Oleracea Extract

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: Evenly spread moderate amount on skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT CC COLOR BASE ROSE 
titanium dioxide, zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.28 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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-460-02	1 in 1 CARTON	10/01/2017	11/01/2019
1	NDC: 69106-460-01	30 mL in 1 BOTTLE, PUMP; 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	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-460)

Revised: 1/2020

Document Id: 9c6544ec-124d-48cb-b831-7c7c34465fac

34390-5

Set id: 2a00a132-7084-419d-be81-34f71e40f73e

Version: 2

Effective Time: 20200108

 

F&CO Co., Ltd.