ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone and titanium dioxide kit

ZO MEDICAL by

Drug Labeling and Warnings

ZO MEDICAL by is a Prescription medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Sanitor Corporation, PhytogenX, Inc., PAKLAB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MELAMIN™ Skin Bleaching & Correcting Crème

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

After cleansing, 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 (Aqua), Ascorbic Acid, Glycolic Acid, Cetyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Stearyl Alcohol, Tocopheryl Acetate, BHT, Disodium EDTA, Methylparaben, Propylparaben, Saponins, Sodium Metabisulfite.

MELAMIX™ Skin Lightener & Blending Crème

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

Combine 1g tretinoin with 1 pump Melamix™ at night to affected areas or as directed by a physician, directly following Melamin™ for a gradual bleaching of hyperpigmented skin conditions. (See enclosed package insert for full prescribing information.)

	Mild	Start 1-2×/week, increasing as tolerated.
	Moderate	Use every other day, increasing as tolerated.
	Aggressive	Use every AM and PM as tolerated. Always use sunscreen protection.

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 (Aqua), Glycolic Acid, Glycerin, Cetyl Alcohol, Ethylhexyl Palmitate, Ascorbic Acid, Sodium Lauryl Sulfate, Phenyl Trimethicone, Saponins, Tocopheryl Acetate, Methylparaben, Propylparaben, Sodium Metabisulfite, BHT, Disodium EDTA.

OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50

Drug Facts

Active ingredient

Titanium Dioxide 8%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop and ask a doctor if rash occurs.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Other information

• Store product in a cool place away from direct heat and sunlight.
• You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

Directions

• For full protection, apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• For children under 6 months of age: ask a doctor.
• Sun Protection Measures. Spending time in the sun increases your risk off skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • - Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • - Wear long-sleeved shirts, pants, hats and sunglasses.
• Apply to all skin exposed to the sun.

Inactive ingredients

Water (Aqua), Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja Extract, Silica, C13-14 Isoparaffin, Laureth-7.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® MULTI-THERAPY HYDROQUINONE SYSTEM

NDC: 42851-131-98

ZO® MEDICAL
BY ZEIN OBAGI, MD

RX
ONLY

INGREDIENTS AND APPEARANCE

ZO MEDICAL   ZO MULTI-THERAPY HYDROQUINONE SYSTEM
hydroquinone and titanium dioxide kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42851-131

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-131-98	1 in 1 CARTON	03/01/2014

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 TUBE	60 g
Part 4	1 BOTTLE, PLASTIC	30 mL
Part 5	1 BOTTLE, PUMP	30 mL

Part 1 of 5

MELAMIN SKIN BLEACHING AND CORRECTING 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 42851-030
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
Ascorbic Acid (UNII: PQ6CK8PD0R)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Cetyl Alcohol (UNII: 936JST6JCN)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glycolic Acid (UNII: 0WT12SX38S)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-030-32	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		01/01/2012

Part 2 of 5

MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 42851-031
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
Ascorbic Acid (UNII: PQ6CK8PD0R)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Cetyl Alcohol (UNII: 936JST6JCN)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylhexyl Palmitate (UNII: 2865993309)
Glycerin (UNII: PDC6A3C0OX)
Glycolic Acid (UNII: 0WT12SX38S)
Methylparaben (UNII: A2I8C7HI9T)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-031-32	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		01/01/2012

Part 3 of 5

ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide lotion

Product Information
Item Code (Source)	NDC: 42851-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.08 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL LACTATE (UNII: G5SU0BFK7O)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
MELAMINE (UNII: N3GP2YSD88)
ERYTHRITOL (UNII: RA96B954X6)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-052-60	60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2013

Part 4 of 5

ZO MEDICAL GLYCOGENT EXFOLIATION ACCELERATOR CONCENTRATION 
cleansing (cold creams, cleansing lotions, liquids, and pads) 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	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
INGR	STEAPYRIUM CHLORIDE (UNII: C9842BS3SX)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM CARBONATE (UNII: 45P3261C7T)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)

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		01/01/2012

Part 5 of 5

OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) 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	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	JOJOBA BUTTER (UNII: XIA46H803R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CURDLAN (UNII: 6930DL209R)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
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	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	C14-22 ALCOHOLS (UNII: B1K89384RJ)
INGR	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
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		01/11/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2014

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Sanitor Corporation		797472792	MANUFACTURE(42851-131)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(42851-131)

Establishment
Name	Address	ID/FEI	Business Operations
PAKLAB		790530976	MANUFACTURE(42851-131)