FDA.reportPublic FDA data

ZO SKIN HEALTH Daily Skincare Program

Manufacturer
ZO Skin Health, Inc. | Lifetech Resources, LLC | Thibiant International, Inc. | DIAMOND WIPES INTERNATIONAL, INC. | PakLab
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:13

Label at a glance#

ProductZO SKIN HEALTH Daily Skincare Program
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

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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...

Storage and handling

Protect this product from excessive heat and direct sun. You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.2%

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.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.
  • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

DAILY SKINCARE PROGRAM

NDC 42851-166-15

EXFOLIATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-166-152021-07-23C16284748780-1c7ccaba7-22c5-fd44-e053-dadaa90aa01bZO ® SKIN HEALTH Daily Skincare Program NDC 42851-166

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-166-15ZO SKIN HEALTH Daily Skincare Program1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-166ZO SKIN HEALTH DAILY SKINCARE PROGRAM (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 1 package rows20200618_e706e046-21ea-4e18-aca1-1145ef29366f.zip

Products#

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

DailyMed product names page 1 of 3 · 116 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-16642851-166-15

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 147 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
GLYCERINPDC6A3C0OXINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
DISODIUM COCOAMPHODIACETATE18L9G3U51MINGR
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WINGR
SODIUM HYDROXIDE55X04QC32IINGR
POWDERED CELLULOSESMD1X3XO9MINGR
MANNITOL3OWL53L36AINGR
CAPRYLIC ALCOHOLNV1779205DINGR
NIACIN2679MF687AINGR
AMMONIUM LACTATE67M901L9NQINGR
SALICYLIC ACIDO414PZ4LPZINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
LIMONENE, (+)-GFD7C86Q1WINGR
LINALOOL, (+/-)-D81QY6I88EINGR
NIACINAMIDE25X51I8RD4INGR
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOINGR
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2INGR
BIOSACCHARIDE GUM-1BB4PU4V09HINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
HEXYLENE GLYCOLKEH0A3F75JINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
PHENOXYETHANOLHIE492ZZ3TINGR
CHROMIUM HYDROXIDE GREENRV8FT8XF5RINGR
POLYETHYLENE GLYCOL 400B697894SGQINGR
SODIUM BICARBONATE8MDF5V39QOINGR
MAGNESIUM OXIDE3A3U0GI71GINGR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BINGR
GLYCERINPDC6A3C0OXINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
OLETH-20YTH167I2AGINGR
TRIHYDROXYSTEARIN06YD7896S3INGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
PEG-100 STEARATEYD01N1999RINGR
MINERAL OILT5L8T28FGPINGR
WATER059QF0KO0RINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
TEA TREE OILVIF565UC2GINGR

Source Document#

Source XML

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
a84dd8a6-b82a-8959-e053-2a95a90a085ce706e046-21ea-4e18-aca1-1145ef29366f2020-06-17WarningsExact identifier
spl id: a84dd8a6-b82a-8959-e053-2a95a90a085c
spl set id: e706e046-21ea-4e18-aca1-1145ef29366f

Reported adverse events (FAERS/openFDA)#

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