Skin Lightening Cream

Drug Labeling and Warnings

Drug Details [pdf]

SKIN LIGHTENING CREAM- hydroquinone cream cream 
Urban Skin Solutions

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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Skin Lightening Cream

ACTIVE INGREDIENT -Hydroquinone 2%

Skin Lightening

INACTIVE INGREDIENTS: PURIFIED OXYGENATED WATER (AQUA), CERTIFIED ORGANIC ALOE VERA GEL, USP GLYCERIN, DMAE, ALPHA LIPOIC ACID, VITAMIN B5, I-CARNOSINE, 2% KOJIC ACID, LACTIC ACID, VITAMIN E, LECITHIN, ALL TRANS RETINOL (VITAMIN A), HYALURONIC ACID, NAPCA, CHAMOMILE EXTRACT, SAGE EXTRACT, HORSETAIL EXTRACT, CENTELLA ASIATICA EXTRACT, EYEBRIGHT, MAGNESIUM ASCORBYL PHOSPHATE, AND GRAPESEED EXTRACT.

SKIN LIGHTENING CREAM 
hydroquinone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
DEANOL (UNII: 2N6K9DRA24)
PANTOTHENIC ACID (UNII: 19F5HK2737)
CARNOSINE (UNII: 8HO6PVN24W)
KOJIC ACID (UNII: 6K23F1TT52)
LACTIC ACID (UNII: 33X04XA5AT)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYALURONIC ACID (UNII: S270N0TRQY)
VITAMIN A (UNII: 81G40H8B0T)
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
EUPHRASIA STRICTA (UNII: C9642I91WL)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CLARY SAGE (UNII: U3HSK5JC0Q)
EQUUS CABALLUS HAIR (UNII: 4F35XG0149)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1604-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	07/25/2016	01/01/2017

Labeler - Urban Skin Solutions (807305417)

Registrant - Urban Skin Solutions (807305417)

Establishment
Name	Address	ID/FEI	Business Operations
Urban Skin Solutions		807305417	label(70809-1604) , api manufacture(70809-1604)

Revised: 6/2019

Document Id: 8b3525b6-d6c6-6a16-e053-2995a90af9f6

34390-5

Set id: 387a2035-0fa2-27ff-e054-00144ff88e88

Version: 2

Effective Time: 20190613