Drugplain

Umbra Sheer Mineral Cream SPF 30 12 g/60mL

Zinc Oxide · CREAM · Drunk Elephant, LLC

No Recall History
Plain English

Umbra Sheer Mineral Cream SPF 30 is a cream containing zinc oxide at 12 g/60mL, taken topical. Manufactured by Drunk Elephant, LLC.

Key Facts

Brand Name
Umbra Sheer Mineral Cream SPF 30
Generic Name
Zinc Oxide
NDC Code (Product)
69455-163
Manufacturer
Drunk Elephant, LLC
Strength
12 g/60mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
06/11/2024

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 skin aging caused by the sun

Dosage & Administration

Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 SPF value of 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 Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. 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.

Frequently Asked Questions

What is Umbra Sheer Mineral Cream SPF 30 used for?

Umbra Sheer Mineral Cream SPF 30 contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is Umbra Sheer Mineral Cream SPF 30 a controlled substance?

Umbra Sheer Mineral Cream SPF 30 is not classified as a controlled substance by the DEA.

What is the generic name for Umbra Sheer Mineral Cream SPF 30?

The generic name for Umbra Sheer Mineral Cream SPF 30 is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for Umbra Sheer Mineral Cream SPF 30 12 g/60mL?

The NDC (National Drug Code) for Umbra Sheer Mineral Cream SPF 30 12 g/60mL is 69455-163, listed by Drunk Elephant, LLC.