GZE AHA BODYLOTION- arbutin,citric acid lotion

GZE AHA BodyLotion by

Drug Labeling and Warnings

GZE AHA BodyLotion 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

Citric acid 1%

Arbutin 1%

INACTIVE INGREDIENT

Water

Cyclopentasiloxane

Dimethicone

Glycerin

Diethylhexyl Carbonate

Titanium Dioxide

Butylene Glycol

C12-15 Alkyl Benzoate

Polymethylsilsesquioxane

Polyglyceryl-4Diisostearate/

Polyhydroxystearate/Sebacate

Ethylhexyl Methoxycinnamate

Cetyl PEG/PPG-10/1Dimethicone

Imidazolidinyl Urea

Benzophenone-3

Cetearyl Dimethicone Crosspolymer

Sodium Chloride

Hydrolyzed Extensin

Phospholipids

Parfum

Phenoxyethanol

Glutathione

Niacinamide

Betaine

PURPOSE

Softens old body cuticles.

INDICATIONS & USAGE

Apply over your body daily in the morning and before bed.

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

Apply over your body daily in the morning and before bed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE AHA BODYLOTION 
arbutin,citric acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF)	ARBUTIN	1 g  in 100 g
CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	CITRIC ACID, 1-STEARYL ESTER	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BETAINE (UNII: 3SCV180C9W)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
N-(1,3,4-TRIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: ENL2IA4WGW)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PARFUMIDINE (UNII: A2Q2LHC6MA)
PENTAMETHYL CYCLOPENTASILOXANE (UNII: K29QC5YCW8)
OXYBENZONE (UNII: 95OOS7VE0Y)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
GLYCERIN (UNII: PDC6A3C0OX)
GLUTATHIONE (UNII: GAN16C9B8O)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-002-01	40 g in 1 TUBE; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/15/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-002)