DR. C. TUNA LUMI RADIANCE BRIGHTENING- octocrylene, octinoxate, avobenzone cream

Dr. C. Tuna Lumi Radiance Brightening by

Drug Labeling and Warnings

Dr. C. Tuna Lumi Radiance Brightening by is a Otc medication manufactured, distributed, or labeled by Farmasi US LLC, TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS

Octocrylene 5.5%

Ethylhexyl Methoxycinnamate 6%

Butyl Methoxydibenzoylmethane 2%

PURPOSE

Sunscreen

USE

Helps to maintain skin brightness and balance uneven skin tone in regular use. 

WARNINGS

For external use only. Avoid contact with eyes. If contact occurs rinse thoroughly with water. 

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

DIRECTIONS

Recommended to use twice a day.

INACTIVE INGREDIENTS

Water/Aqua, Cetearyl Alcohol, Stearic Acid, Mineral Oil / Paraffinum Liquidum, Isopropyl Myristate, Glycerin, Titanium Dioxide, Ceteareth-20, Ceteareth-12, Cetearyl Alcohol, Cetyl Pamitate, Glyceryl Stearate, Butylene Glycol, Silica, Ammonium Polyacrylate, Hydrolyzed Algae Extract, Pancratium Maritimum Extract, Dimethicone, Phenoxyethanol, Fragrance / Parfum, Niacinamide, Triethanolamine, Ethylhexylglycerin, Tocopheryl Acetate.

Questions or Comments? 

info@farmasius.com 1 786 238 7338

Monday - Friday (9 a.m - 6 p.m. EST)

SPL UNCLASSIFIED SECTION

Manufactured by: Tan-Alize Kozmetik ve Temizlik Ürünleri San. ve. Tic. A.S. Ömerli Mah. Uran Cad. No: 32 / 34797 Cekmeköy / ISTANBUL 

Made in TURKEY

EU REsponsible Person: Farmasi Central Europe S.R.O. Stará Vajnorská Republika. Distributed By: FARMASI US LLC 2315 NW 107 TH AVE, STE 1B 12, DORAL , FL 33172.

Package Labeling

INGREDIENTS AND APPEARANCE

DR. C. TUNA LUMI RADIANCE BRIGHTENING 
octocrylene, octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	55 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-003-01	1 in 1 BOX	01/08/2020
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/08/2020

Labeler - Farmasi US LLC (113303351)

Establishment
Name	Address	ID/FEI	Business Operations
TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		365979587	manufacture(74690-003)