FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 24 g/100mL

ZINC OXIDE · CREAM · Peer Pharm Ltd.

No Recall History

Plain English

FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 is a prescription cream containing zinc oxide at 24 g/100mL, taken topical. Manufactured by Peer Pharm Ltd..

Key Facts

Brand Name: FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50
Generic Name: ZINC OXIDE
NDC Code (Product): 69435-1413
Manufacturer: Peer Pharm Ltd.
Strength: 24 g/100mL
Dosage Form: CREAM
Route: TOPICAL
Marketing Status: HUMAN OTC DRUG
Application #: M020
Marketing Start: 01/14/2025

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

Directions • Apply liberally 15 minutes before sun exposure. • 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 this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures. • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • For children under 6 months of age: Ask a doctor.

Dosage & Administration

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.

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 swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 used for?

FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 contains ZINC OXIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 a controlled substance?

FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50?

The generic name for FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 24 g/100mL?

The NDC (National Drug Code) for FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 24 g/100mL is 69435-1413, listed by Peer Pharm Ltd..

Product NDC

69435-1413

Package NDC

69435-1413-1

Other Zinc Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)