Broad Spectrum Sunscreen SPF 30
Broad Spectrum Sunscreen SPF 30 is an FDA drug label for the active ingredient OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3% manufactured by S&C Hampton Sun 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 20260422.
- Generic name
- OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%
- Manufacturer
- S&C Hampton Sun LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87170-007
- Application
- M020
- Label effective
- 20260422
About this product
Broad Spectrum Sunscreen SPF 30 is an FDA-registered drug product whose active ingredient is OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%. It is labelled by S&C Hampton Sun LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87170-007, application M020, label effective 20260422. 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 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3% 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
Uses Uses ■ helps prevent sunburn
Dosage & Administration
Directions Directions apply liberally to cool, dry skin 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 a long-sleeve shirts, pants, hats, and sunglasses. • children under 6 months: Ask a doctor.
Warnings
Warnings For external use only. Flammable : Do not use white smoking or near heat or flame. Do not use on damaged or broken skin. When using this product ■ keep out of eyes. Rinse eyes with water to remove. Stop use and ask a doctor if rash occurs.
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-1175-2023 | Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01 | HUMANRACE | Class II | Ongoing | 20230927 |
| D-1176-2023 | Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002 | HUMANRACE | Class II | Ongoing | 20230927 |
Frequently asked questions
What is Broad Spectrum Sunscreen SPF 30 used for?
Uses Uses ■ helps prevent sunburn
Who makes Broad Spectrum Sunscreen SPF 30?
S&C Hampton Sun LLC is the labeler of record for Broad Spectrum Sunscreen SPF 30.
What form does Broad Spectrum Sunscreen SPF 30 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 Sunscreen SPF 30 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 Broad Spectrum Sunscreen SPF 30 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.