Amish Origins SPF 15 Lip Balm
Amish Origins SPF 15 Lip Balm is an FDA drug label for the active ingredient OCTINOXATE, OCTOCRYLENE, OXYBENZONE manufactured by Amish Origins 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 20170406.
- Generic name
- OCTINOXATE, OCTOCRYLENE, OXYBENZONE
- Manufacturer
- Amish Origins
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 62212-350
- Application
- part352
- Label effective
- 20170406
About this product
Amish Origins SPF 15 Lip Balm is an FDA-registered drug product whose active ingredient is OCTINOXATE, OCTOCRYLENE, OXYBENZONE. It is labelled by Amish Origins taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 62212-350, application part352, label effective 20170406. 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 OCTINOXATE, OCTOCRYLENE, OXYBENZONE are most often described in connection with: prevents sunburns. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Prevents Sunburns
Dosage & Administration
Directions Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.
Warnings
Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.
Frequently asked questions
What is Amish Origins SPF 15 Lip Balm used for?
Uses Prevents Sunburns
Who makes Amish Origins SPF 15 Lip Balm?
Amish Origins is the labeler of record for Amish Origins SPF 15 Lip Balm.
What form does Amish Origins SPF 15 Lip Balm 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 Amish Origins SPF 15 Lip Balm 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 Amish Origins SPF 15 Lip Balm 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.