Product Safety and Adverse Event Reporting

Last updated: August 29, 2026

How to report a reaction

If a product of ours causes irritation, a rash, or any other reaction, tell us. Email hello@ozeralabs.com with the product name, what happened, and when it started. You can also use our contact page.

This is the reporting route required on our labels under section 609(a) of the Federal Food, Drug, and Cosmetic Act. Use this route to contact us about a product reaction.

If a reaction is severe — difficulty breathing, swelling of the face or throat, widespread rash — seek medical attention first. Report it to us afterwards.

What we do with a report

Ozera Labs is the Responsible Person for these products under the Modernization of Cosmetics Regulation Act (MoCRA). That means the following obligations are ours, not our manufacturer’s:

• We keep a record of every adverse event reported to us, for the period the regulation requires.
• We report serious adverse events to the FDA within 15 business days of receiving them, as required by law.
• We are responsible for ensuring and maintaining records supporting adequate safety substantiation for each product.

We will also refund you. You do not need to return the product and you do not need to be inside the 30-day return window — see our Refund Policy.

Using our products safely

• Patch test before first use. Read our guide to trying a product on a small area, and follow the directions on the product label. A home test cannot rule out every reaction.
• For external use only. Avoid contact with the eyes. If a product gets in your eye, rinse thoroughly with water.
• Discontinue use if irritation occurs. Do not push through it.
• Keep out of reach of children.
• Introduce one product at a time, with about two weeks between, so you know what caused a problem if one appears.
• If you are pregnant or nursing, consult your physician before using products containing retinol.
• Store in a cool, dry place, away from direct sunlight. Follow any storage directions on the label.

Ingredients

The complete ingredient list (INCI) for every product is published in full under “Full ingredient list” on that product’s page before you buy. If you have a known allergy, read it there first. We do not publish ingredient percentages, because we have not had them verified to us in writing.

What our products are

Ozera Labs products are cosmetics. They are not drugs and are not intended to diagnose, treat, cure or prevent any disease or medical condition. Nothing on this site is medical advice. If you have a skin condition, talk to a doctor.

Contact

hello@ozeralabs.com
Ozera Labs — [BUSINESS ADDRESS — to be completed]