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

Image of cartonImage of carton

IT RADIANT CC COLOR BASE ROSE 
titanium dioxide, zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69106-460
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.28 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:69106-460-021 in 1 CARTON10/01/201711/01/2019
1NDC:69106-460-0130 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(69106-460)

Revised: 1/2020
 
F&CO Co., Ltd.