Sunscreen
Sunscreen is an FDA drug label for the active ingredient BROAD SPECTRUM SPF 30 manufactured by 1226 W AESTHETICS 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 20260909.
- Generic name
- BROAD SPECTRUM SPF 30
- Manufacturer
- 1226 W AESTHETICS
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 82031-3019
- Application
- M020
- Label effective
- 20260909
About this product
Sunscreen is an FDA-registered drug product whose active ingredient is BROAD SPECTRUM SPF 30. It is labelled by 1226 W AESTHETICS taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82031-3019, application M020, label effective 20260909. It is one of 8 FDA drug label records sharing the active ingredient BROAD SPECTRUM SPF 30. 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 are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, 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 ), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage & Administration
Directions apply liberally 15 minutes before sun exposure do not spray directly on face - spray into hands and apply to face hold approximately 4 - 6 inches from skin to spray rub into skin evenly to ensure appropriate coverage use in a well-ventilated area avoid inhaling or exposing others to spray do not apply in windy conditions 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 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 children under 6 months: Ask a doctor
Warnings
Warnings For external use only Flammable: Do not use near heat, flame, or while smoking Do not use on damaged or broken skin When using this product : Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120° F Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
More products with the same ingredient
BROAD SPECTRUM SPF 30Meraki Protective Mist Sunscreen
View labelNHLMA Skin Defense Sunscreen
View labelProtect Sport Sunscreen
View labelSoleil Defense Sunscreen
View labelStay Ageless Sunscreen
View labelHow products containing BROAD SPECTRUM SPF 30 compare
FDA lists 8 drug label records with BROAD SPECTRUM SPF 30 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 |
|---|---|---|---|
| — | — | 1226 W AESTHETICS | 1 |
| — | — | AMARA MED SPA LLC | 1 |
| — | — | Charleston Dermatology, P.C. | 1 |
| — | — | Concierge Choice LLC | 1 |
| — | — | MERAKI MEDICAL SPA LLC | 1 |
Recall and safety notices
5 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-0854-2026 | MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China | SHANTOU Qiwei industrial Co., Ltd | Class II | Ongoing | 20260930 |
| D-0825-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733 | Allies Group Inc. | Class II | Ongoing | 20260909 |
| D-0824-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293 | Allies Group Inc. | Class II | Ongoing | 20260909 |
| D-0826-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853 | Allies Group Inc. | Class II | Ongoing | 20260909 |
| D-0823-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224 | Allies Group Inc. | Class II | Ongoing | 20260909 |
Frequently asked questions
What is Sunscreen used for?
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Who makes Sunscreen?
1226 W AESTHETICS is the labeler of record for Sunscreen. 8 FDA label records share the active ingredient BROAD SPECTRUM SPF 30, 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 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 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?
Yes. 8 FDA drug label records list BROAD SPECTRUM SPF 30 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 Sunscreen been recalled?
5 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.