Non-Tinted Mineral Sunscreen 160 mg/g

Zinc Oxide · CREAM · WECARE FRISCO PLLC

No Recall History

Plain English

Non-Tinted Mineral Sunscreen is a cream containing zinc oxide at 160 mg/g, taken topical. Manufactured by WECARE FRISCO PLLC.

Key Facts

Brand Name: Non-Tinted Mineral Sunscreen
Generic Name: Zinc Oxide
NDC Code (Product): 85747-226
Manufacturer: WECARE FRISCO PLLC
Strength: 160 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 11/16/2022

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

DIRECTIONS: • Apply liberally 15 minutes before sun exposure. • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: 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 sun protection measures including: • Limit time in the sun, especially from 10 am-2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging cuased by the sun. Apply liberally 15 minutes befor sun exposure.

Warnings

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. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Non-Tinted Mineral Sunscreen used for?

Non-Tinted Mineral Sunscreen contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is Non-Tinted Mineral Sunscreen a controlled substance?

Non-Tinted Mineral Sunscreen is not classified as a controlled substance by the DEA.

What is the generic name for Non-Tinted Mineral Sunscreen?

The generic name for Non-Tinted Mineral Sunscreen is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for Non-Tinted Mineral Sunscreen 160 mg/g?

The NDC (National Drug Code) for Non-Tinted Mineral Sunscreen 160 mg/g is 85747-226, listed by WECARE FRISCO PLLC.

Product NDC

85747-226

Package NDC

85747-226-50

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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)