FDA.reportPublic FDA data

ZO SKIN HEALTH RENEW

Manufacturer
ZO Skin Health, Inc. | Lifetech Resources, LLC. | Thibiant International, Inc.
Effective date
2020-06-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:02

Label at a glance#

ProductZO SKIN HEALTH RENEW
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 children under 6 months of age: ask a doctor reapply at least every two hours 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 measure...

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 ingredients

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 occurs

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
  • children under 6 months of age: ask a doctor
  • reapply at least every two hours
  • 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

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

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

RE NEW

OFFECTS ® HYDRATING CLEANSER
40 mL / 1.5 Fl. Oz.

OFFECTS ® EXFOLIATING POLISH
Net Wt. 16.2 g / 0.57 Oz.

OCLIPSE ® SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
15 mL / 0.5 Fl. Oz.

NDC 42851-163-01

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-163-012021-07-23C16284748780-1c7ccaba7-1089-fd44-e053-dadaa90aa01bZO ® SKIN HEALTH RENEW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-053-01ZO SKIN HEALTH RENEW15 mL in 1 BOTTLE, PUMPLOTION15 mL82 mg in 1mL2
42851-163-01ZO SKIN HEALTH RENEW1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-053ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC20200618_3da6948a-d424-40b4-85da-0df8783de580.zip
42851-163ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 2 package rows20200618_3da6948a-d424-40b4-85da-0df8783de580.zip

Products#

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

DailyMed product names page 1 of 2 · 79 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-16342851-163-01
42851-05342851-053-01

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 87 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
SODIUM COCOYL ISETHIONATE518XTE8493INGR
SODIUM METHYL COCOYL TAURATEJVL98CG53GINGR
GLYCERINPDC6A3C0OXINGR
STEARIC ACID4ELV7Z65APINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
PEG-100 STEARATEYD01N1999RINGR
GLYCOL DISTEARATE13W7MDN21WINGR
DISODIUM COCOAMPHODIACETATE18L9G3U51MINGR
CETYL ALCOHOL936JST6JCNINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM CHLORIDE451W47IQ8XINGR
PANTHENOLWV9CM0O67ZINGR
UREA8W8T17847WINGR
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2INGR
SODIUM HYDROXIDE55X04QC32IINGR
TREHALOSEB8WCK70T7IINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
SODIUM GLYCOLATEB75E535IMIINGR
TRIACETINXHX3C3X673INGR
CHLORPHENESINI670DAL4SZINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
HYALURONATE SODIUMYSE9PPT4THINGR
SORBIC ACIDX045WJ989BINGR
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JINGR
ALLANTOIN344S277G0ZINGR
D&C RED NO. 339DBA0SBB0LINGR
FD&C YELLOW NO. 6H77VEI93A8INGR
POLYETHYLENE GLYCOL 400B697894SGQINGR
SODIUM BICARBONATE8MDF5V39QOINGR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BINGR
MAGNESIUM OXIDE3A3U0GI71GINGR
GLYCERINPDC6A3C0OXINGR
OLETH-20YTH167I2AGINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
TRIHYDROXYSTEARIN06YD7896S3INGR
PEG-100 STEARATEYD01N1999RINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZINGR
VITAMIN A PALMITATE1D1K0N0VVCINGR

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
a84c34a3-264e-5f2a-e053-2995a90a9c3e3da6948a-d424-40b4-85da-0df8783de5802020-06-17WarningsExact identifier
spl id: a84c34a3-264e-5f2a-e053-2995a90a9c3e
spl set id: 3da6948a-d424-40b4-85da-0df8783de580

Reported adverse events (FAERS/openFDA)#

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