zinc oxide, titanium dioxide

Manufacturer
MATCHCo Inc.
Effective date
2016-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:31

Label at a glance#

Productzinc oxide, titanium dioxide
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Uses helps prevent sunburn higher SPF gives more sunburn protection Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Drug Facts

Active ingredients Purpose

Titanium Dioxide 4.0% Sunscreen

Zinc Oxide 5.9% Sunscreen

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

OTHER SAFETY INFORMATION

Other information

protect the product in this container from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Titanium Dioxide 4.9% Sunscreen

Zinc Oxide 5.9% Sunscreen

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dist. By.

MATCHCo, Inc

Santa Monica, CA 90401

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70798-415-222020-01-31C16284748780-19d75b9d0-40cf-f424-e053-dadaa90a57ce32aa75a5-49b3-35ab-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70798-415-22zinc oxide, titanium dioxide30 g in 1 BOTTLE, GLASSCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70798-415ZINC OXIDE, TITANIUM DIOXIDE CREAM [MATCHCO INC.]1Legacy NDC, 1 package rows20160712_32aa75a5-49b3-35ab-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70798-41570798-415-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 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
32aa75a5-49b4-35ab-e054-00144ff88e8832aa75a5-49b3-35ab-e054-00144ff88e882016-05-12WarningsExact identifier
spl id: 32aa75a5-49b4-35ab-e054-00144ff88e88
spl set id: 32aa75a5-49b3-35ab-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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