FDA.reportPublic FDA data

ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:31:46

Label at a glance#

ProductZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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 and as needed. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 protectio...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 1.0%Sunscreen
Zinc Oxide 20.0%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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone,Dimethicone/Vinyl DimethiconeCrosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Ecklonia Kurome Extract, Glycine Soja (Soybean) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,
Hexyl Laurate, Polyglyceryl-4 Isostearate, Tribehenin, Bisabolol, Cetyl PEG/PPG-10/1 Dimethicone,Water, Glycerin, Squalane, Polymethyl Methacrylate, Dimethiconol, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Caprylyl Glycol, Behenyl Behenate, Melanin, Tocopheryl Acetate, Ethyl Ferulate, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Ethylhexylglycerin, Tocopherol,
Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

SPL UNCLASSIFIED SECTION

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

Changes to: Uses, Directions

RECENT MAJOR CHANGES SECTION

Addition of: 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

Changed formatting of Directions.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH



BY ZEIN OBAGI MD

NDC 42851-060-30

SUNSCREEN + PRIMER



BROAD-SPECTRUM



SPF 30

ZOX 12 ™

30 mL / 1 Fl. Oz.

US Sunscreen Primer SPF 30 Full Box.JPGUS Sunscreen Primer SPF 30 Full Box.JPG

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-060-152022-10-06C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-302022-10-06C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-752022-10-06C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-152022-07-29C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-302022-07-29C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
42851-060-752022-07-29C16284748780-1e4f33bdf-af99-d8a0-e053-dadaa90a6e4eZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-060-15ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-15ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3015 mL in 1 BOTTLE, PUMPCREAM158
42851-060-30ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-30ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3030 mL in 1 BOTTLE, PUMPCREAM308
42851-060-75ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 301 in 1 CARTONCREAM18
42851-060-75ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 3075 mL in 1 BOTTLE, PUMPCREAM758

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-060ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ZO SKIN HEALTH, INC.]8Current NDC, Legacy NDC, 6 package rows20241031_9a4f5be1-da04-48b9-897a-57f4a3d9d1ec.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-06042851-060-15, 42851-060-30, 42851-060-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOYBEANL7HT8F1ZODIACT
ROSEMARYIJ67X351P9IACT
HEXYL LAURATE4CG9F9W01QIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
TRIBEHENIN8OC9U7TQZ0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARIC ACID4ELV7Z65APIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BEHENYL BEHENATEK8NU647RJ0IACT
ETHYL FERULATE5B8915UELWIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LEVOMENOL24WE03BX2TIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
FERRIC OXIDE RED1K09F3G675IACT
ALUMINUM OXIDELMI26O6933IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
GLYCYRRHIZA URALENSIS42B5YD8F0KIACT
SUNFLOWER OIL3W1JG795YIIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
ECKLONIA KUROME802YF989GTIACT

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
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
ndc (package): 42851-060-15
ndc (package): 42851-060-30
ndc (package): 42851-060-75
ndc (product): 42851-060
ndc11 (package): 42851006075
ndc11 (package): 42851006015
ndc11 (package): 42851006030
spl id: 25a24c79-21ec-795b-e063-6294a90a7b97
spl set id: 9a4f5be1-da04-48b9-897a-57f4a3d9d1ec

Reported adverse events (FAERS/openFDA)#

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