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

It Radiant CC Color Base Lavender by

Drug Labeling and Warnings

It Radiant CC Color Base Lavender 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 LAVENDER- 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 4.43%, 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, Methyl Methacrylate Crosspolymer, Tridecane, Ultramarines (CI 77007), Caprylyl Methicone, Disteardimonium Hectorite, Tribehenin, Magnesium Sulfate, Phenoxyethanol, Mica (CI 77019), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Cetearyl Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Aluminum Hydroxide, Stearic Acid, Dimethicone, Ethylhexylglycerin, Triethoxycaprylylsilane, Adenosine, Fragrance(Parfum), Disodium EDTA, Red 30 (CI 73360), Trehalose, Butylene Glycol, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hyaluronate, Centella Asiatica Extract, Portulaca Oleracea Extract, Pyrus Malus (Apple) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Diospyros Kaki Fruit Extract, Juglans Regia (Walnut) Seed Extract, Morus Alba Fruit Extract, Punica Granatum Fruit Extract, Pyrus Communis (Pear) Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Lavandula Angustifolia (Lavender) Oil

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

IT RADIANT CC COLOR BASE LAVENDER 
titanium dioxide, zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.32 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.47 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.50 g  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-440-02	1 in 1 CARTON	10/01/2017	11/01/2019
1	NDC: 69106-440-01	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2017	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-440)

Revised: 1/2020

Document Id: 003e1f1c-59fd-44ed-8951-4140222f7a2a

34390-5

Set id: f6d77249-1d6d-4370-97cd-71c3141590e9

Version: 2

Effective Time: 20200108

 

F&CO Co., Ltd.