OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted 17.5 g/100g

Zinc Oxide · CREAM · Allure Labs

No Recall History

Plain English

OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted is a cream containing zinc oxide at 17.5 g/100g, taken topical. Manufactured by Allure Labs.

Key Facts

Brand Name: OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted
Generic Name: Zinc Oxide
NDC Code (Product): 62742-4228
Manufacturer: Allure Labs
Strength: 17.5 g/100g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 08/14/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective506 reports

macular degeneration453 reports

off label use313 reports

pyrexia303 reports

nausea284 reports

pain280 reports

malaise259 reports

weight decreased235 reports

therapeutic product effect incomplete213 reports

headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses – Helps prevent sunburn If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Direction- Apply liberally 15 minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including: Limit time in the sun. especially from 10 am to 2 pm Wear long-sleeved shirts, pants hats and sunglasses.

Warnings

Warning – For external use only

Frequently Asked Questions

What is OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted used for?

OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted a controlled substance?

OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted is not classified as a controlled substance by the DEA.

What is the generic name for OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted?

The generic name for OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted 17.5 g/100g?

The NDC (National Drug Code) for OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted 17.5 g/100g is 62742-4228, listed by Allure Labs.

Product NDC

62742-4228

Package NDC

62742-4228-2

Other Zinc Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)