IT RADIANT CC by F&CO Co., Ltd. / Cosmax, Inc

Drug Details [pdf]

IT RADIANT CC- octinoxate, titanium dioxide, octisalate 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: Ethylhexyl Methoxycinnamate 6.7%, Titanium Dioxide 4.26%, Ethylhexyl Salicylate 2.5%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Butylene Glycol, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, Niacinamide, Dicaprylyl Carbonate, Cetyl Ethylhexanoate, Octyldodecanol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone, Mica (CI 77019), Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-2 Stearate, PEG-100 Stearate, PEG-10 Dimethicone, Carbomer, Triethanolamine, Silica, Aluminum Hydroxide, Stearic Acid, Sodium Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Fragrance(Parfum), Isohexadecane, Ethylhexylglycerin, Triethoxycaprylylsilane, Xanthan Gum, Polysorbate 80, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Ultramarines (CI 77007), Lavandula Angustifolia (Lavender) Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Anthemis Nobilis Flower Water, Imperata Cylindrica Root Extract, Ipomoea Purpurea Extract, Lilium Candidum Flower Water, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Paeonia Albiflora Flower Extract, Sigesbeckia Orientalis Extract, Lactobacillus Ferment, Lactococcus Ferment, Milk Protein, PEG-8, Saccharomyces Ferment Filtrate, Rabdosia Rubescens Extract, Cassia Angustifolia Seed Polysaccharide, Aesculus Hippocastanum (Horse Chestnut) Extract, Alcohol, Benzyl Alcohol, Methylparaben, Dehydroacetic Acid, Potassium Sorbate, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

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.

DESCRIPTION

Indication and usage: After skin care, equally spread a moderate amoount of skin. Use it in substitution for makeup base to double next step makeup effect, which maintains smooth and bright skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

IT RADIANT CC
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.01 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.27 mg in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.75 mg in 30 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69106-100-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	07/01/2014	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2014	11/01/2019

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(69106-100)

Revised: 1/2020

Document Id: 269b4baf-50c5-40c1-b147-a6c2f603cec9

Set id: 92f91524-9e67-4eca-a77b-8547b5cbccd3

Version: 3

Effective Time: 20200108

F&CO Co., Ltd.