Broad Spectrum SPF 30 Sunscreen
Broad Spectrum SPF 30 Sunscreen is an FDA drug label for the active ingredient BROAD SPECTRUM SPF 30 SUNSCREEN manufactured by Raining Rose 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 20231018.
- Generic name
- BROAD SPECTRUM SPF 30 SUNSCREEN
- Manufacturer
- Raining Rose
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 65692-0567
- Application
- M020
- Label effective
- 20231018
About this product
Broad Spectrum SPF 30 Sunscreen is an FDA-registered drug product whose active ingredient is BROAD SPECTRUM SPF 30 SUNSCREEN. It is labelled by Raining Rose taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 65692-0567, application M020, label effective 20231018. It is one of 2 FDA drug label records sharing the active ingredient BROAD SPECTRUM SPF 30 SUNSCREEN. 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 BROAD SPECTRUM SPF 30 SUNSCREEN are most often described in connection with: helps prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Helps prevent Sunburn
Dosage & Administration
Directions Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours Children under 6 months of age: 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 sunprotection measures including: limit time in the sun, especially from 10a.m.-2p.m. wear long sleeved shirts, pants, hats and sunglasses.
Warnings
For external use only Do not use on damaged or broken skin Stop use and ask a doctor if * rash occurs When using this product keep out of eyes. Rinse with water to remove.
How products containing BROAD SPECTRUM SPF 30 SUNSCREEN compare
FDA lists 2 drug label records with BROAD SPECTRUM SPF 30 SUNSCREEN 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 |
|---|---|---|---|
| — | — | Raining Rose | 2 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
1 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-0975-2022 | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL) | Family Dollar Stores, Llc. | Class II | Ongoing | 20220608 |
Frequently asked questions
What is Broad Spectrum SPF 30 Sunscreen used for?
Helps prevent Sunburn
Who makes Broad Spectrum SPF 30 Sunscreen?
Raining Rose is the labeler of record for Broad Spectrum SPF 30 Sunscreen. 2 FDA label records share the active ingredient BROAD SPECTRUM SPF 30 SUNSCREEN, 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 Broad Spectrum SPF 30 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 Broad Spectrum SPF 30 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 BROAD SPECTRUM SPF 30 SUNSCREEN?
Yes. 2 FDA drug label records list BROAD SPECTRUM SPF 30 SUNSCREEN 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 Broad Spectrum SPF 30 Sunscreen been recalled?
1 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.