ZO MEDICAL

Manufacturer
ZO Skin Health, Inc. | Sanitor Corporation | PhytogenX, Inc. | PAKLAB
Effective date
2016-04-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:24

Label at a glance#

ProductZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM
Active ingredientHydroquinone, TITANIUM DIOXIDE
Label structure24 sections

Indications and 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.

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.)

Storage and handling

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

Label contents#

Full prescribing information#

MELAMIN™ Skin Bleaching & Correcting Crème

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.)

MildStart 1-2×/week, increasing as tolerated.
ModerateUse every other day, increasing as tolerated.
AggressiveUse every AM and PM as tolerated. Always use sunscreen protection.

WARNINGS

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® MULTI-THERAPY HYDROQUINONE SYSTEM

NDC 42851-131-98

ZO® MEDICAL
BY ZEIN OBAGI, MD

RX
ONLY

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Ingredients#

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Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efcdd64c-192f-e759-e053-2a95a90a8ea33f9bd7a0-3aa1-484d-a72a-e75d4f81f7e72022-12-14WarningsExact identifier
spl set id: 3f9bd7a0-3aa1-484d-a72a-e75d4f81f7e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.