GZE NIACINAMIDE WHITE SET BOX- niacinamide kit

GZE NIACINAMIDE WHITE SET BOX by

Drug Labeling and Warnings

GZE NIACINAMIDE WHITE SET BOX by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Nicotinamide,Vitamin c

INACTIVE INGREDIENT

Water

Glycerol

Propylene Glycol

Butylene Glycol

Allantoin

Diazolidinyl Urea

Methylparaben

Sodium Hyaluronate

Disodium Edta

Mentha Arvensis Extract

Pelargonium Graveolens Flower/Leaf/Stem Extract

Portulaca Oleracea Flower/Leaf/Stem Extract

Chrysanthellum Indicum Extract

Aloe Yohjyu Matsu Ekisu

3-o-ethyl Ascorbic Acid

PURPOSE

Skin lightening.

INDICATIONS & USAGE

After cleansing, apply a base of Niacinamide Mist, pat to absorb, then apply 2-3 drops of Niacinamide Serum to the face and finish with Niacinamide Cream.

WARNINGS

For external use only.

STOP USE

Stop use and ask a doctor if rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

After cleansing, apply a base of Niacinamide Mist, pat to absorb, then apply 2-3 drops of Niacinamide Serum to the face and finish with Niacinamide Cream.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE NIACINAMIDE WHITE SET BOX 
niacinamide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-109

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-109-01	1 in 1 KIT; Type 0: Not a Combination Product	01/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 JAR	50 g  in 281
Part 2	1 BOTTLE, DROPPER	20 mL  in 281
Part 3	1 BOTTLE, SPRAY	80 mL  in 281

Part 1 of 3

NIACINAMIDE SERUM 
nicotinamide cream

Product Information
Item Code (Source)	NDC: 83566-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-6 SORBITAN STEARATE (UNII: 3453J8557N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
GLUTATHIONE (UNII: GAN16C9B8O)
MINERAL OIL (UNII: T5L8T28FGP)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
.ALPHA.-BUTYLDIMETHYLSILYL-AND .OMEGA.-3-METHACRYLOXYPROPYLDIMETHYLSILYL-TERMINATED POLYDIMETHYLSILOXANE (1000 MW) (UNII: QU3C8D8GQY)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-007-01	50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/14/2023

Part 2 of 3

NIACINAMIDE SERUM 
niacinamide liquid

Product Information
Item Code (Source)	NDC: 83566-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)
CHRYSANTHELLUM INDICUM WHOLE (UNII: YPX537PA31)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALLANTOIN (UNII: 344S277G0Z)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-006-01	20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/14/2023

Part 3 of 3

NIACINAMIDE TONER 
vitamin c spray

Product Information
Item Code (Source)	NDC: 83566-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUGARCANE (UNII: 81H2R5AOH3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ORANGE PEEL WAX (UNII: 0U715N387C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON PEEL WAX (UNII: 20G0UPO0TI)
BILBERRY (UNII: 9P2U39H18W)
ACER SACCHARINUM WHOLE (UNII: 3PIN4S77JQ)
CRANBERRY (UNII: 0MVO31Q3QS)
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-005-01	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/01/2024

Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-109)