SPF15 lip balm 01
SPF15 lip balm 01 is an FDA drug label for the active ingredient OCTOCRYLENE, OCTISALATE manufactured by Cosmuses Cosmetics (Ningbo) Co., 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 20260908.
- Generic name
- OCTOCRYLENE, OCTISALATE
- Manufacturer
- Cosmuses Cosmetics (Ningbo) Co., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 82953-009
- Application
- M020
- Label effective
- 20260908
About this product
SPF15 lip balm 01 is an FDA-registered drug product whose active ingredient is OCTOCRYLENE, OCTISALATE. It is labelled by Cosmuses Cosmetics (Ningbo) Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82953-009, application M020, label effective 20260908. 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 OCTOCRYLENE, OCTISALATE are most often described in connection with: helps prevent, sunburn higher, spf gives. 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 Higher SPF gives more sunburn protection
Dosage & Administration
Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: ask a doctor Sun protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
warnings For external use only.
Frequently asked questions
What is SPF15 lip balm 01 used for?
Uses Helps prevent sunburn Higher SPF gives more sunburn protection
Who makes SPF15 lip balm 01?
Cosmuses Cosmetics (Ningbo) Co., Ltd. is the labeler of record for SPF15 lip balm 01.
What form does SPF15 lip balm 01 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 SPF15 lip balm 01 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.
Has SPF15 lip balm 01 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.