111 SKIN SUNSCREEN SPF 50 19.5 g/100mL

Zinc Oxide · SOLUTION · Bentley Laboratories, LLC

No Recall History

Plain English

111 SKIN SUNSCREEN SPF 50 is a solution containing zinc oxide at 19.5 g/100mL, taken topical. Manufactured by Bentley Laboratories, LLC.

Key Facts

Brand Name: 111 SKIN SUNSCREEN SPF 50
Generic Name: Zinc Oxide
NDC Code (Product): 54111-190
Manufacturer: Bentley Laboratories, LLC
Strength: 19.5 g/100mL
Dosage Form: SOLUTION
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 05/23/2025

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 Directions), decreases the risk of skin cancer and early aging caused by the sun.

Dosage & Administration

Directions • Apply generously and evenly to face and neck 15-20 minutes before sun exposure. • Reapply at least every 2 hours • Use a water-resistant sunscreen when swimming or sweating. • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early aging. To reduce this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - Limiting time in the sun, especially from 10 a.m. - 2 p.m. - Wear long-sleeved shirts, pants, hats, and sunglasses. • Children under 6 months: Ask a doctor.

Warnings

Warnings Do not use on damaged or broken skin. For external use only. When using this produc t keep out of eyes. If product gets into the eyes, rinse with water to remove Stop use and consult a doctor if rash occurs.

Frequently Asked Questions

What is 111 SKIN SUNSCREEN SPF 50 used for?

111 SKIN SUNSCREEN SPF 50 contains Zinc Oxide. It is a solution taken topical. Consult your doctor for specific uses.

Is 111 SKIN SUNSCREEN SPF 50 a controlled substance?

111 SKIN SUNSCREEN SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for 111 SKIN SUNSCREEN SPF 50?

The generic name for 111 SKIN SUNSCREEN SPF 50 is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for 111 SKIN SUNSCREEN SPF 50 19.5 g/100mL?

The NDC (National Drug Code) for 111 SKIN SUNSCREEN SPF 50 19.5 g/100mL is 54111-190, listed by Bentley Laboratories, LLC.

Product NDC

54111-190

Package NDC

54111-190-01

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)