ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening

Manufacturer
ZO Skin Health, Inc. | Milbar Laboratories, Inc. | G.S. COSMECEUTICAL USA, INC. | PakLab | Thibiant International, Inc.
Effective date
2016-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:33

Label at a glance#

ProductZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening
Active ingredientTitanium Dioxide
Label structure10 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

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 of 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 ot...

Storage and handling

Store product in a cool place away from direct heat and sunlight. You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618

Label contents#

Full prescribing information#

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: 5 Technology Dr. #100, 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 of 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, 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 (Soybean) 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® MEDICAL
BY ZEIN OBAGI MD

NDC 42851-158-60

ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Skin Brightening

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-158-602020-01-31C16284748780-19d75b9d0-2008-f424-e053-dadaa90a57ceZO ® MEDICAL ZO ® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-052-60ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening60 g in 1 TUBELOTION60 g0.08 g in 1g1
42851-158-60ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-052ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]1Legacy NDC20160714_73246324-eede-4933-9921-bb2b59642964.zip
42851-158ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]1Legacy NDC, 2 package rows20160714_73246324-eede-4933-9921-bb2b59642964.zip

Products#

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

DailyMed product names page 1 of 3 · 114 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-15842851-158-60
42851-05242851-052-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 143 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50473cf6-b9d0-4865-8767-358eb8b7980873246324-eede-4933-9921-bb2b596429642016-07-12WarningsExact identifier
spl id: 50473cf6-b9d0-4865-8767-358eb8b79808
spl set id: 73246324-eede-4933-9921-bb2b59642964

Reported adverse events (FAERS/openFDA)#

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