IT RADIANT GLOW BB by F&CO Co., Ltd.

IT RADIANT GLOW BB by

Drug Labeling and Warnings

IT RADIANT GLOW BB by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IT RADIANT GLOW BB CLASSIC BEIGE- titanium dioxide, octinoxate, zinc oxide 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 9.69%, Ethylhexyl Methoxycinnamate 5.0%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Methylpropanediol, Butylene Glycol, Glycerin, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Methyl Methacrylate Crosspolymer, Hexyl Laurate, Sodium Chloride, Dicaprylyl Carbonate, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Sorbitan Isostearate, Iron Oxides (CI 77492), Ozokerite, Caprylic/Capric Glycerides, Ethylhexylglycerin, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Aluminum Hydroxide, Iron Oxides (CI 77491), Stearic Acid, Fragrance(Parfum), Triethoxycaprylylsilane, Isopropyl Myristate, Iron Oxides (CI 77499), Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Persea Gratissima (Avocado) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Adenosine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Caprylic/Capric Triglyceride, Portulaca Oleracea Extract, Chamomilla Recutita (Matricaria) Flower Extract, Centella Asiatica Extract

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION:
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

How to Use

How to Use: Use the spatula to take a small amount and massage gently in circular motions. Rinse well with lukewarm water, or use tissue to wipe off the balm with gentle strokes.

Dosage & Administration

Dosage & Administration:
it Radiant Glow BB Cream features high-quality multibalancing formula that glides softly on skin while moisturizes, protects, and conceals imperfects with a natural healthy glow.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT GLOW BB  CLASSIC BEIGE
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.90 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.50 mg  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.88 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-080-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	07/01/2014	11/01/2019

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

Labeler - F&CO Co., Ltd. (690166186)

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

Establishment
Name	Address	ID/FEI	Business Operations
F&CO Co., Ltd.		690166186	manufacture(69106-080)

Revised: 1/2020

Document Id: 36a45938-18d4-4123-8d77-b02388ad09b3

34390-5

Set id: 76fd70a9-a0b3-4121-a96a-d8d3d1fe411d

Version: 2

Effective Time: 20200108

 

F&CO Co., Ltd.