Private Label SPF45 Water Resistant Paraben Free Sunscreen
Private Label SPF45 Water Resistant Paraben Free Sunscreen is an FDA drug label for the active ingredient OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN manufactured by Swiss-American CDMO, LLC 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 20231107.
- Generic name
- OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN
- Manufacturer
- Swiss-American CDMO, LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 60232-0006
- Application
- M020
- Label effective
- 20231107
About this product
Private Label SPF45 Water Resistant Paraben Free Sunscreen is an FDA-registered drug product whose active ingredient is OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN. It is labelled by Swiss-American CDMO, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60232-0006, application M020, label effective 20231107. 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, OCTISALATE, ZINC OXIDE SUNSCREEN are most often described in connection with: helps prevent, sun protection, measures see, directions decrease, 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), decrease 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 80 minutes of swimming or sweating, immediately after towel drying and 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 this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m., wear long-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.
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 physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Frequently asked questions
What is Private Label SPF45 Water Resistant Paraben Free Sunscreen used for?
Uses Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun
Who makes Private Label SPF45 Water Resistant Paraben Free Sunscreen?
Swiss-American CDMO, LLC is the labeler of record for Private Label SPF45 Water Resistant Paraben Free Sunscreen.
What form does Private Label SPF45 Water Resistant Paraben Free 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 Private Label SPF45 Water Resistant Paraben Free 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.
Has Private Label SPF45 Water Resistant Paraben Free 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.