Statement Of Identity Section
Drug Facts
Active ingredients Purpose
Titanium Dioxide 4.0% Sunscreen
Zinc Oxide 5.9% Sunscreen
Zinc Oxide, Titanium Dioxide
FDA Label NDC 70798-415
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Matchco Inc. for the product Zinc Oxide, Titanium Dioxide (NDC 70798-415). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding statement of identity section, indications and usage section, warnings section, other safety information, otc - active ingredient section, otc - stop use section, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And 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
Dist. By.
MATCHCo, Inc
Santa Monica, CA 90401
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