Perbelle CC SPF43 UVA UVB Broad Spectrum
Perbelle CC SPF43 UVA UVB Broad Spectrum is an FDA drug label for the active ingredient TITANIUM DIOXIDE manufactured by Perbelle Cosmetics Global 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 20231201.
- Generic name
- TITANIUM DIOXIDE
- Manufacturer
- Perbelle Cosmetics Global Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 81186-000
- Application
- M020
- Label effective
- 20231201
About this product
Perbelle CC SPF43 UVA UVB Broad Spectrum is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE. It is labelled by Perbelle Cosmetics Global Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 81186-000, application M020, label effective 20231201. It is one of 71 FDA drug label records sharing the active ingredient TITANIUM DIOXIDE. 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 TITANIUM DIOXIDE are most often described in connection with: helps protect, 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 protect sunburns 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 at least every 2 hours. Use a water reistant sunscreen if swimming or sweating. spending time in the sun increases your risk of skin cancer and early skin aging. To decrese this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Sun Protection Measures Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age Ask doctor.
Warnings
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 Poison Control Center right away.
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View labelHow products containing TITANIUM DIOXIDE compare
FDA lists 71 drug label records with TITANIUM DIOXIDE 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 |
|---|---|---|---|
| — | — | Amway Corp | 16 |
| — | — | Farmasi US LLC | 12 |
| — | — | Orveon Global US LLC | 7 |
| — | — | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | 4 |
| — | — | 3LAB, Inc | 3 |
Frequently asked questions
What is Perbelle CC SPF43 UVA UVB Broad Spectrum used for?
Uses Helps protect sunburns 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 Perbelle CC SPF43 UVA UVB Broad Spectrum?
Perbelle Cosmetics Global Ltd. is the labeler of record for Perbelle CC SPF43 UVA UVB Broad Spectrum. 71 FDA label records share the active ingredient TITANIUM DIOXIDE, 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 Perbelle CC SPF43 UVA UVB Broad Spectrum 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 Perbelle CC SPF43 UVA UVB Broad Spectrum 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 TITANIUM DIOXIDE?
Yes. 71 FDA drug label records list TITANIUM DIOXIDE 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 Perbelle CC SPF43 UVA UVB Broad Spectrum 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.