ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone kit

ZO Skin Health Multi-Therapy Hydroquinone System by

Drug Labeling and Warnings

ZO Skin Health Multi-Therapy Hydroquinone System by is a Prescription medication manufactured, distributed, or labeled by ZO Skin Health, Inc., G.S. COSMECEUTICAL USA, INC., PhytogenX, Inc., PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MELAMIN™ Skin Bleaching & Correcting Crème

INDICATIONS & USAGE

Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

DOSAGE AND ADMINISTRATION

Apply 2 pumps (1 g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

WARNINGS

Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

SUNBURN ALERT

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, C10-16 Alcohols, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stachys Officinalis Flower/ Leaf/Stem Extract, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

SPL UNCLASSIFIED SECTION

MELAMIX™ Skin Lightener & Blending Crème

INDICATIONS & USAGE

Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

DOSAGE AND ADMINISTRATION

Apply 2 pumps (1 g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

WARNINGS

Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

SUNBURN ALERT

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Water, Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Phenoxyethanol, Ascorbic Acid, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica (Broccoli) Sprout Powder, Ascorbyl Palmitate, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stachys Officinalis Flower/Leaf/ Stem Extract, Saponins, Sodium Sulfite.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

MULTI-THERAPY HYDROQUINONE SYSTEM

NDC: 42851-185-79

MELAMIN™ Net Wt. 32 g / 1.12 Oz.
EXFOLIATION ACCELERATOR 30 mL / 1 Fl. Oz.
MELAMIX™ Net Wt. 32 g / 1.12 Oz.
DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM 
hydroquinone kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42851-185

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-185-79	1 in 1 CARTON	03/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	32 g
Part 2	1 BOTTLE, PLASTIC	32 g
Part 3	1 BOTTLE, PLASTIC	30 mL
Part 4	1 BOTTLE, PUMP	30 mL

Part 1 of 4

MELAMIN SKIN BLEACHING AND CORRECTING HYDROQUINONE 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 42851-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetyl Alcohol (UNII: 936JST6JCN)
Chlorphenesin (UNII: I670DAL4SZ)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Glycerin (UNII: PDC6A3C0OX)
Glycolic Acid (UNII: 0WT12SX38S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Maltodextrin (UNII: 7CVR7L4A2D)
Phenoxyethanol (UNII: HIE492ZZ3T)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Tocopherol (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-032-32	32 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2018

Part 2 of 4

MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 42851-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Ethylhexyl Palmitate (UNII: 2865993309)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Maltodextrin (UNII: 7CVR7L4A2D)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Aminopropyl Dihydrogen Phosphate (UNII: D5J0Q2CM4V)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Glycolic Acid (UNII: 0WT12SX38S)
BROCCOLI SPROUT (UNII: 128UH9LOAE)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Chlorphenesin (UNII: I670DAL4SZ)
Caprylyl Glycol (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38)
Sodium Sulfite (UNII: VTK01UQK3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-033-32	32 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2018

Part 3 of 4

ZO SKIN HEALTH EXFOLIATION ACCELERATOR 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycolic Acid (UNII: 0WT12SX38S)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
INGR	Propylene Glycol (UNII: 6DC9Q167V3)
INGR	AMMONIA (UNII: 5138Q19F1X)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Squalane (UNII: GW89575KF9)
INGR	Steapyrium Chloride (UNII: C9842BS3SX)
INGR	Allantoin (UNII: 344S277G0Z)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/01/2018

Part 4 of 4

ZO SKIN HEALTH DAILY POWER DEFENSE 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Cetearyl Isononanoate (UNII: P5O01U99NI)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	Pentylene Glycol (UNII: 50C1307PZG)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	Steareth-20 (UNII: L0Q8IK9E08)
INGR	C14-22 Alcohols (UNII: B1K89384RJ)
INGR	Cetearyl Glucoside (UNII: 09FUA47KNA)
INGR	C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	Retinol (UNII: G2SH0XKK91)
INGR	1,2-Hexanediol (UNII: TR046Y3K1G)
INGR	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
INGR	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	MANDARIN OIL (UNII: NJO720F72R)
INGR	LEMON OIL (UNII: I9GRO824LL)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
INGR	TANGERINE (UNII: KH3E3096OO)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Farnesol (UNII: EB41QIU6JL)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Palmitoyl Tripeptide-1 (UNII: RV743D216M)
INGR	Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2018

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(42851-185)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(42851-185)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-185)