Drugplain

Mineral Sunscreen SPF 50 225 mg/g

Zinc Oxide Titanium Dioxide · POWDER · Topiderm, Inc.

5 Recalls on Record
Plain English

This powder sunscreen contains zinc oxide and titanium dioxide as active ingredients to protect your skin from the sun's harmful rays. Apply it topically to exposed skin to help prevent sunburn and reduce the risk of skin cancer and early skin aging.

Key Facts

Brand Name
Mineral Sunscreen SPF 50
Generic Name
Zinc Oxide Titanium Dioxide
NDC Code (Product)
51326-125
Manufacturer
Topiderm, Inc.
Strength
225 mg/g
Dosage Form
POWDER
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
10/14/2020

Recall History

5 Recalls on Record
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II10/10/2025

CA BOTANA International, Inc.

CGMP Deviations

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective512 reports
macular degeneration453 reports
off label use321 reports
pyrexia306 reports
nausea286 reports
pain286 reports
malaise262 reports
weight decreased238 reports
therapeutic product effect incomplete215 reports
headache209 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

Drug Facts

Warnings

Warnings For external use only Do not use on broken or damaged 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 Mineral Sunscreen SPF 50 used for?

This powder sunscreen contains zinc oxide and titanium dioxide as active ingredients to protect your skin from the sun's harmful rays. Apply it topically to exposed skin to help prevent sunburn and reduce the risk of skin cancer and early skin aging.

Is Mineral Sunscreen SPF 50 a controlled substance?

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

What is the generic name for Mineral Sunscreen SPF 50?

The generic name for Mineral Sunscreen SPF 50 is Zinc Oxide Titanium Dioxide. There are 7 other brand versions of Zinc Oxide Titanium Dioxide.

What is the NDC code for Mineral Sunscreen SPF 50 225 mg/g?

The NDC (National Drug Code) for Mineral Sunscreen SPF 50 225 mg/g is 51326-125, listed by Topiderm, Inc..