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

it Radiant Brightening by

Drug Labeling and Warnings

it Radiant Brightening 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- dimethicone lotion 
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 (1.0%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Glycerin, Butylene Glycol, Niacinamide, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl Ethylhexanoate, Ethylhexyl Palmitate, Glyceryl Stearate, Cetearyl Alcohol, Trehalose, Pentylene Glycol, Stearic Acid, Phenoxyethanol, Cetearyl Glucoside, PEG-100 Stearate, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Carbomer, Tromethamine, Xanthan Gum, Disodium Gum, Disodium EDTA, Anthemis Nobilis Flower Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceratonia Siliqua (Carob) Seed Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Lilium Candidum Bulb Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, 1,2-Hexandiol, Robinia Pseudoacacia Flower Extract, Benzyl Alcohol, Sodium Benzoate, Citric Acid, Dehydroacetic Acid

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

After prepping your skin with toner, apply to the entire face gently.

DOSAGE & ADMINISTRATION

After prepping your skin with toner, apply to the entire face gently.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

IT RADIANT BRIGHTENING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2.0 mg  in 200 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-280-01200 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(69106-280)

Revised: 1/2020
 
F&CO Co., Ltd.