it Radiant Brightening Essence by F&CO Co., Ltd. / COSMAX INC.

it Radiant Brightening Essence by

Drug Labeling and Warnings

it Radiant Brightening Essence 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 BRIGHTENING ESSENCE- dimethicone 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 INGREDIENT: Dimethicone (3.2%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Glycerin, Propanediol, Niacinamide, Pentylene Glycol, Linum Usitatissimum (Linseed) Seed Extract, Butylene Glycol, C14-22 Alcohols, C12-20 Alkyl Glucoside, Decyl Cocate, Triisostearin, Diamond Powder, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexandiol, Glyceryl Stearate, Cyclomethicone, Panthenol, Phenoxyethanol, Polysilicone-11, Titanium Dioxide (CI 77891), Synthetic Fluorphlogopite, Xanthan Gum, Fragrance, Mica (CI 77019), Disodium EDTA, Silica, Tin Oxide, Anthemis Nobilis Flower Water, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Rose Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Ceratonia Sliqua (Carob) Seed Extract, Robinia Pseudoacacia Flower Extract, Benzyl Alcohol, Sodium Benzoate, Dehydroacetic Acid, Citric Acid, Sodium Polyacrylate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7

PURPOSE

PURPOSE: Skin Protectant

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Apply generously over your face after toner/moisturizer.

DOSAGE & ADMINISTRATION

Apply generously over your face after toner/moisturizer.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

IT RADIANT BRIGHTENING ESSENCE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.96 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-260-0130 mL in 1 CARTON; Type 0: Not a Combination Product03/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/201511/01/2019
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69106-260)

Revised: 1/2020
 
F&CO Co., Ltd.