FDA.reportPublic FDA data

ZO Skin Health Sunscreen Plus Broad-Spectrum SPF 40 Medium

Manufacturer
ZO Skin Health, Inc. | Paramount Cosmetics
Effective date
2019-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:00:46

Label at a glance#

ProductZO Skin Health Sunscreen Plus Broad-Spectrum SPF 40 Medium
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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 reapply: at least every 2 hours use a water resistant sunscreen if swimming or sweating 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 24.4%Sunscreen
Zinc Oxide 23.4%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
  • reapply: at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Hydrogen Dimethicone, Dimethicone, Synthetic Fluorphlogopite, Simmondsia Chinensis (Jojoba) Seed Oil, Water, Ascorbic Acid, Tocopheryl Acetate, Retinyl Palmitate, Triethoxycaprylylsilane, Methicone, Tin Oxide, Melanin, Ethylhexylglycerin, Pentylene Glycol, Phenoxyethanol, Iron Oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 3 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-061-03

SUNSCREEN + POWDER
BROAD-SPECTRUM
SPF 40

ZOX12™

MEDIUM

Net Wt. 3 g / 0.10 Oz.

PRINCIPAL DISPLAY PANEL - 3 g Jar Carton
PRINCIPAL DISPLAY PANEL - 3 g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-061-032023-03-28C16284748780-1c7ccaba7-280e-fd44-e053-dadaa90aa01bZO ® Skin Health Sunscreen + Powder Broad-Spectrum SPF 40 Medium
42851-061-032021-07-23C16284748780-1c7ccaba7-280e-fd44-e053-dadaa90aa01bZO ® Skin Health Sunscreen + Powder Broad-Spectrum SPF 40 Medium

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-06142851-061-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
MicaV8A1AW0880IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
Hexamethylene Diisocyanate/Trimethylol Hexyllactone CrosspolymerWB5K9Y35Y9IACT
Jojoba ButterXIA46H803RIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
Dimethicone92RU3N3Y1OIACT
Jojoba Oil724GKU717MIACT
Water059QF0KO0RIACT
Ascorbic AcidPQ6CK8PD0RIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Vitamin A Palmitate1D1K0N0VVCIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Methicone (20 Cst)6777U11MKTIACT
Stannic OxideKM7N50LOS6IACT
Ethylhexylglycerin147D247K3PIACT
Pentylene Glycol50C1307PZGIACT
PhenoxyethanolHIE492ZZ3TIACT
Ferric Oxide Red1K09F3G675IACT

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
f7f950ce-0388-5390-e053-6394a90a2fbdaabf543a-3941-47c2-8752-f6aa7c0676fb2023-03-28WarningsExact identifier
spl set id: aabf543a-3941-47c2-8752-f6aa7c0676fb

Reported adverse events (FAERS/openFDA)#

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