Blue Lizard Kids SPF 50 Sunscreen
Blue Lizard Kids SPF 50 Sunscreen is an FDA drug label for the active ingredient OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE manufactured by Crown Laboratories 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 20260501.
- Generic name
- OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE
- Manufacturer
- Crown Laboratories
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0316-2062
- Application
- M020
- Label effective
- 20260501
About this product
Blue Lizard Kids SPF 50 Sunscreen is an FDA-registered drug product whose active ingredient is OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE. It is labelled by Crown Laboratories taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0316-2062, application M020, label effective 20260501. It is one of 2 FDA drug label records sharing the active ingredient OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE. 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 OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE are most often described in connection with: helps prevent, photodamage caused, uva uvb, exposure higher, spf gives, sunburn protection, measures see, directions decreases. 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 and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun
Dosage & Administration
Directions • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only • 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 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • Reapply to dry skin : • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours Keep out of reach of children
Warnings
Warnings • When using this product • Keep out of eyes. Rinse with water to remove • Stop use and ask doctor if • Rash or irritation occurs • Do not use • On damaged or broken skin • If allergic to any ingredient • If swallowed, get medical help or contact a Poison Control Center
More products with the same ingredient
OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDEHow products containing OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE compare
FDA lists 2 drug label records with OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE 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 |
|---|---|---|---|
| — | — | Crown Laboratories | 2 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1338-2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 | Crown Laboratories | Class II | Terminated | 20200701 |
| D-1339-2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15 | Crown Laboratories | Class II | Terminated | 20200701 |
Frequently asked questions
What is Blue Lizard Kids SPF 50 Sunscreen used for?
Uses Helps prevent sunburn and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun
Who makes Blue Lizard Kids SPF 50 Sunscreen?
Crown Laboratories is the labeler of record for Blue Lizard Kids SPF 50 Sunscreen. 2 FDA label records share the active ingredient OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE, 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 Blue Lizard Kids SPF 50 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 Blue Lizard Kids SPF 50 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 OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE?
Yes. 2 FDA drug label records list OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE 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 Blue Lizard Kids SPF 50 Sunscreen been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.