TIZO ULTRA NON TINTED MINERAL SUNSCREEN
TIZO ULTRA NON TINTED MINERAL SUNSCREEN is an FDA drug label for the active ingredient ZINC OXIDE 20% manufactured by Fallien Cosmeceuticals, LTD administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260528.
- Generic name
- ZINC OXIDE 20%
- Manufacturer
- Fallien Cosmeceuticals, LTD
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 58892-072
- Application
- M020
- Label effective
- 20260528
About this product
TIZO ULTRA NON TINTED MINERAL SUNSCREEN is an FDA-registered drug product whose active ingredient is ZINC OXIDE 20%. It is labelled by Fallien Cosmeceuticals, LTD taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 58892-072, application M020, label effective 20260528. It is one of 4 FDA drug label records sharing the active ingredient ZINC OXIDE 20%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing ZINC OXIDE 20% are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses ■ helps prevent 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.
Dosage & Administration
Directions ■ apply liberally 15 minutes before sun exposure. Reapply: ■ after 40 minutes of swimming or sweating ■ Immediately after towel drying ■ at least every 2 hours. Sun protection measures: Spending time In the sun Increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures lncludlng: ■ limit time In the sun, especlally from 10am to 2pm ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months: ask a doctor ■ do not spray directly Into face. Spray on hands then apply to face ■ use In well-ventilated area.
Warnings
Warnings: For external use only Do not use on damaged or broken skin. When using this product ■ keep out of eyes. Rinse eyes with water to remove. Stop use and ask a doctor if rash occurs.
More products with the same ingredient
ZINC OXIDE 20%Hampton Sun SPF 50 Baby Mineral
View labelThe Naked Bee SPF 50 Mineral Sunscreen
View labelZinc Oxide Skin Protectant
View labelHow products containing ZINC OXIDE 20% compare
FDA lists 4 drug label records with ZINC OXIDE 20% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Aldermed Inc. | 1 |
| — | — | Fallien Cosmeceuticals, LTD | 1 |
| — | — | S&C Hampton Sun LLC | 1 |
| — | — | The Naked Bee | 1 |
| — | — | — | — |
Frequently asked questions
What is TIZO ULTRA NON TINTED MINERAL SUNSCREEN used for?
Uses ■ helps prevent 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.
Who makes TIZO ULTRA NON TINTED MINERAL SUNSCREEN?
Fallien Cosmeceuticals, LTD is the labeler of record for TIZO ULTRA NON TINTED MINERAL SUNSCREEN. 4 FDA label records share the active ingredient ZINC OXIDE 20%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does TIZO ULTRA NON TINTED MINERAL SUNSCREEN come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is TIZO ULTRA NON TINTED MINERAL SUNSCREEN prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing ZINC OXIDE 20%?
Yes. 4 FDA drug label records list ZINC OXIDE 20% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has TIZO ULTRA NON TINTED MINERAL SUNSCREEN been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.