DR. COLOR EFFECT RED- niacinamide cream

DR. COLOR EFFECT RED by

Drug Labeling and Warnings

DR. COLOR EFFECT RED by is a Otc medication manufactured, distributed, or labeled by ES PURE VINE INC., LAB & Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Dipropylene Glycol, Glycerin, Butylene Glycol, Ethylhexyl Stearate, Cyclopentasiloxane, Biosaccharide Gum-1, Sodium Polyacrylate, Hydrolyzed Glycosaminoglycans, Punica Granatum Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Chamaemorus Fruit Extract, Lycium Chinense Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Lepidium Sativum Sprout Extract, Carthamus Tinctorius (Safflower) Flower Extract, Rosa Rugosa Flower Extract, Paeonia Albiflora Flower Extract, Tulipa Darwin Flower Extract, Camellia Japonica Flower Extract, Rosa Hybrid Flower Extract, Polyglutamic Acid, Beta-Glucan, Sodium Hyaluronate, Lithospermum Erythrorhizon Root Oil, Bis-Stearyl Peg/PPG-8/6 SMDI/Peg-400 Copolymer, Allantoin, Betaine, Panthenol, Rosa Damascena Callus Culture Extract, Sodium Polyacryloyldimethyl Taurate, Hydrogenated Polydecene, Trideceth-10, Caprylhydroxamic Acid, Caprylyl Glycol, Boswellia Serrata Resin Extract, Dipotassium Glycyrrhizate, Adenosine, Rose Flower Oil, Ethylhexylglycerin, 1,2-Hexanediol, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indications & Usage: Apply smoothly on the entire face in the morning and night.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product after toner and essence. To feel stronger effect, please use it with RED SERUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. COLOR EFFECT RED 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69679-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGARIN (UNII: 0416TL8388)
VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)
RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)
LEPIDIUM SATIVUM WHOLE (UNII: 0FL88F2R2Q)
ABELMOSCHUS MANIHOT FLOWER (UNII: 7HR1YQC68U)
PAEONIA SUFFRUTICOSA FLOWER OIL (UNII: P3X14HXC1L)
TULIPA KAUFMANNIANA BULB (UNII: 831WJ3WD14)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ROSA RUGOSA FLOWER (UNII: 969IQC5YJU)
1,4-DIPHENYL-1,3-BUTADIENE (UNII: CTQ3U893LX)
ALLANTOIN (UNII: 344S277G0Z)
DIHYDROXYETHYL STEARAMINE OXIDE (UNII: G67739LV1T)
PANTHENOL (UNII: WV9CM0O67Z)
ROSA DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-10 (UNII: G624N6MSBA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLENE GLYCOL (UNII: FC72KVT52F)
GLYCERIN (UNII: PDC6A3C0OX)
1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
POMEGRANATE (UNII: 56687D1Z4D)
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CAMELLIA JAPONICA FLOWER OIL (UNII: 5CXP06X16D)
GLATIRAMER ACETATE (UNII: 5M691HL4BO)
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ROSA CANINA WHOLE (UNII: P5R39F12N2)
POLYGALIC ACID (UNII: XCC6WEA55L)
CURDLAN (UNII: 6930DL209R)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69679-020-01	50 mL in 1 CARTON; Type 0: Not a Combination Product	02/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2016

Labeler - ES PURE VINE INC. (079733519)

Registrant - LAB & Company Inc. (688284779)

Establishment
Name	Address	ID/FEI	Business Operations
LAB & Company Inc.		688284779	manufacture(69679-020)