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

It Radiant CC Color Base Mint by

Drug Labeling and Warnings

It Radiant CC Color Base Mint 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 MINT- 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 4.13%, Zinc Oxide 4.90%, Ethylhexyl Methoxycinnamate 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Butylene Glycol Dicaprylate/Dicaprate, Dipropylene Glycol, Glycerin, 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, Chromium Oxide Greens (CI 77288), Stearic Acid, Dimethicone, Synthetic Fluorphlogopite, Ethylhexylglycerin, Triethoxycaprylylsilane, Adenosine, Fragrance(Parfum), Disodium EDTA, Mica (CI 77019), Trehalose, Methyl Methacrylate Crosspolymer, Butylene Glycol, Tocopherol, Silica, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hyaluronate, Centella Asiatica Extract, Citrus Aurantifolia (Lime) Fruit Extract, Portulaca Oleracea Extract, Mentha Rotundifolia Leaf 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

Image of cartonImage of carton

IT RADIANT CC COLOR BASE MINT 
titanium dioxide, zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.23 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.47 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.50 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-450-021 in 1 CARTON10/01/201711/01/2019
1NDC: 69106-450-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201711/01/2019
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69106-450)

Revised: 1/2020
 
F&CO Co., Ltd.