Drugplain

Non-Tinted Mineral Sunscreen 80 mg/g

Titanium Dioxide, Zinc Oxide · CREAM · HSC MIAMI, INC

No Recall History
Plain English

Non-Tinted Mineral Sunscreen is a cream containing titanium dioxide, zinc oxide at 80 mg/g, taken topical. Manufactured by HSC MIAMI, INC.

Key Facts

Brand Name
Non-Tinted Mineral Sunscreen
Generic Name
Titanium Dioxide, Zinc Oxide
NDC Code (Product)
85376-202
Manufacturer
HSC MIAMI, INC
Strength
80 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
01/06/2025

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 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 Titanium Dioxide, 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 Titanium Dioxide, Zinc Oxide. There are 12 other brand versions of Titanium Dioxide, Zinc Oxide.

What is the NDC code for Non-Tinted Mineral Sunscreen 80 mg/g?

The NDC (National Drug Code) for Non-Tinted Mineral Sunscreen 80 mg/g is 85376-202, listed by HSC MIAMI, INC.