ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)

Manufacturer
ZO Skin Health, Inc. | Bentley Laboratories LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:49:28

Label at a glance#

ProductZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)
Active ingredientZINC OXIDE
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
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

OTC - ASK DOCTOR SECTION
  • ​ If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ 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.
■ 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.
■ Protect the product in this container from excessive
heat and direct sun.
■ You may report a serious adverse reaction
to: 9685 Research Dr., Irvine, CA 92618

Other Information

OTHER SAFETY INFORMATION

  • 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.
  • Protect the product in this container from excessive heat and direct sun.
  • 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, Bisabolol, Triethoxycaprylylsilane, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol, Iron Oxides.

SPL UNCLASSIFIED SECTION

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

Made in USA with US & imported materials

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-049-27

SUNSCREEN + POWDR BROAD-SPECTRUM SPF 45

ZOX12™

LIGHT

Net Wt. 2.7 g / 0.09 Oz.

049-27 Box049-27 Box

res

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
42851-049-27ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)2.7 g in 1 BOTTLE, WITH APPLICATORPOWDER2.79
42851-049-27ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)1 in 1 CARTONPOWDER19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-049ZO SKIN HEALTH SUNSCREEN PLUS POWDER BROAD-SPECTRUM SPF 45 (LIGHT) (ZINC OXIDE) POWDER [ZO SKIN HEALTH, INC.]9Current NDC, Legacy NDC, 2 package rows20241229_be25489e-c3bf-77c5-e053-2a95a90a30de.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-04942851-049-27

Ingredients#

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

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

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 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
ndc (package): 42851-049-27
ndc (product): 42851-049
ndc11 (package): 42851004927
spl id: 9245ef3b-6b5c-406c-a8d5-b93c6c59591c
spl set id: be25489e-c3bf-77c5-e053-2a95a90a30de

Reported adverse events (FAERS/openFDA)#

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