it Radiant CC Sun Base by F&CO Co., Ltd. / Cosmax, Inc

it Radiant CC Sun Base by

Drug Labeling and Warnings

it Radiant CC Sun Base 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 SUN BASE- titanium dioxide, octinoxate, 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (8.89%), Ethylhexyl Methoxycinnamate (6.7%), Ethylhexyl Salicylate (4.0%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasilloxane, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Pentylene Glycol, Hydrogenated Poly(C6-14 Olefin), Polysorbate 60, PEG-10 Dimethicone, Phenoxyethanol, Triceteareth-4 Phosphate, Glycol Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-100 Stearate, PEG-2 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Stearic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Iron Oxides (CI 77492), Alumina, Isohexadecane, Mica(CI 77019), Tromethamine, Fragrance, Ethylhexylglycerin, Polysorbate 80, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Adenosine, Disodium EDTA, Iron Oxides (CI 77499), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Calophyllum Inophyllum Seed Oil, Imperata Cylindrica Root Extract, Cananga Odorata Flower Extract, Lavandula Angustifolia (Lavender) Flower Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Mentha Rotundifolia Leaf Extract, Chamomilla Recutita (Matricaria) Flower Water, Mentha Piperita (Peppermint) Leaf Water, Hibiscus Sabdariffa Flower Extract, Jasminum Officinale (Jasmine) Flower Water, Menthyl PCA, Ethyl Menthane Carboxamide, PEG-8, Vanilla Tahitensis Fruit Extract, Carbomer, Tocopherol

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.

INDICATIONS & USAGE

Indication and usage: Equally spread a moderate amoount of skin. Use it in substitution for sun cream or BB cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT CC SUN BASE 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.66 mg  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.01 mg  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.20 mg  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: 69106-310-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2015	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(69106-310)

Revised: 1/2020

Document Id: 20ace447-a398-463d-b42f-d63ed394d2b2

34390-5

Set id: de82d5bc-b94d-4c3d-bc1c-a43c32f12a1a

Version: 3

Effective Time: 20200108

 

F&CO Co., Ltd.