Drugplain

Simple Mineral Sunscreen SPF 50 250 mg/mL

ZINC OXIDE · CREAM · Simple Sunscreen LLC

No Recall History
Plain English

Zinc oxide sunscreen is a topical cream applied to the skin to protect against sun damage and reduce the risk of sunburn. This over-the-counter product works as a physical sunscreen blocker with SPF 50 protection.

Key Facts

Brand Name
Simple Mineral Sunscreen SPF 50
Generic Name
ZINC OXIDE
NDC Code (Product)
87515-973
Manufacturer
Simple Sunscreen LLC
Strength
250 mg/mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
02/24/2026

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. Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: Ask a doctor. 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 the risk, regularly use a sunscreen with broad spectrum SPF 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-sleeved shirts, pants, hats and sunglasses.

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

Frequently Asked Questions

What is Simple Mineral Sunscreen SPF 50 used for?

Zinc oxide sunscreen is a topical cream applied to the skin to protect against sun damage and reduce the risk of sunburn. This over-the-counter product works as a physical sunscreen blocker with SPF 50 protection.

Is Simple Mineral Sunscreen SPF 50 a controlled substance?

Simple Mineral Sunscreen SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for Simple Mineral Sunscreen SPF 50?

The generic name for Simple Mineral Sunscreen SPF 50 is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for Simple Mineral Sunscreen SPF 50 250 mg/mL?

The NDC (National Drug Code) for Simple Mineral Sunscreen SPF 50 250 mg/mL is 87515-973, listed by Simple Sunscreen LLC.

Product NDC

87515-973

Package NDC

87515-973-00

Other Zinc Brands

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

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