FDA.reportPublic FDA data

ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45

Manufacturer
ZO Skin Health, Inc. | Bentley Laboratories, LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:37:13

Label at a glance#

ProductZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45
Active ingredientZINC OXIDE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

DOSAGE & ADMINISTRATION SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active IngredentsPurpose
Zinc Oxide 25.0%Sunscreen

OTC - PURPOSE SECTION

Purpose    Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Provides high protection against 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

INDICATIONS & USAGE 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

SPL UNCLASSIFIED SECTION

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
STORAGE AND HANDLING SECTION
  • Protect the product in this container from excessive heat and direct sun.
OTC - QUESTIONS SECTION
  • You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica, Hydroxyapatite, Polymethyl Methacrylate, HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Iron Oxides, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-068-27

SUNSCREEN + POWDER
BROAD-SPECTRUM
SPF 45

ZOX12®

MEDIUM

Net Wt. 2.7 g / 0.09 Oz.

US Sunscreen + Powder SPF 45 Medium- Unit CartonUS Sunscreen + Powder SPF 45 Medium- Unit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-068-27ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 452.7 g in 1 JARPOWDER2.75
42851-068-27ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 451 in 1 CARTONPOWDER15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-068ZO SKIN HEALTH SUNSCREEN PLUS POWDER BROAD-SPECTRUM SPF 45 (ZINC OXIDE) POWDER [ZO SKIN HEALTH, INC.]5Current NDC, Legacy NDC, 2 package rows20241115_be3c7ef2-dd08-0f1a-e053-2995a90ae14c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-06842851-068-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
JOJOBA BUTTERXIA46H803RIACT
COPPER789U1901C5IACT
JOJOBA OIL724GKU717MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PENTYLENE GLYCOL50C1307PZGIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
FERRIC OXIDE RED1K09F3G675IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
ETHYL FERULATE5B8915UELWIACT
MICAV8A1AW0880IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.be3c7ef2-dd08-0f1a-e053-2995a90ae14c2024-11-12WarningsExact identifier
ndc (package): 42851-068-27
ndc (product): 42851-068
ndc11 (package): 42851006827
spl id: 26bd572b-a979-0a38-e063-6394a90ad66a
spl set id: be3c7ef2-dd08-0f1a-e053-2995a90ae14c

Reported adverse events (FAERS/openFDA)#

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