Drugplain

Tinted Mineral Sunscreen 80 mg/g

Titanium Dioxide, Zinc Oxide · CREAM · MILESTHETICS LLC

2 Recalls on Record
Plain English

Tinted Mineral Sunscreen is a cream containing titanium dioxide, zinc oxide at 80 mg/g, taken topical. Manufactured by MILESTHETICS LLC.

Key Facts

Brand Name
Tinted Mineral Sunscreen
Generic Name
Titanium Dioxide, Zinc Oxide
NDC Code (Product)
85888-203
Manufacturer
MILESTHETICS LLC
Strength
80 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
07/06/2022

Recall History

2 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

Side Effects Reported to FDA

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

drug ineffective512 reports
macular degeneration453 reports
off label use323 reports
pyrexia306 reports
nausea292 reports
pain289 reports
malaise264 reports
weight decreased239 reports
therapeutic product effect incomplete216 reports
headache211 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • Helps prevent sunburn.Higher SPF gives more sun protection.

Dosage & Administration

DIRECTIONS • Apply liberally 15 minutes before sun exposure. • Reapply after 80 minutes of swimming or sweating , after towel drying, at least every 2 hours • Sun Protection Measures . Spending tme 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses. • children under 6 months: Ask a doctor.

Warnings

WARNINGS For external use only. When using this product : Stop use and ask a doctor if rash occurs.

Frequently Asked Questions

What is Tinted Mineral Sunscreen used for?

Tinted Mineral Sunscreen contains Titanium Dioxide, Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is Tinted Mineral Sunscreen a controlled substance?

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

What is the generic name for Tinted Mineral Sunscreen?

The generic name for 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 Tinted Mineral Sunscreen 80 mg/g?

The NDC (National Drug Code) for Tinted Mineral Sunscreen 80 mg/g is 85888-203, listed by MILESTHETICS LLC.