Drugplain

Physical Sunscreen SPF50 80 min WR 159-100 42.3 g/1000g

titanium dioxide, titanium dioxide sunscreen · LOTION · Swiss-American CDMO, LLC

No Recall History
Plain English

Physical Sunscreen SPF50 80 min WR 159-100 is a lotion containing titanium dioxide, titanium dioxide sunscreen at 42.3 g/1000g, taken topical. Manufactured by Swiss-American CDMO, LLC.

Key Facts

Brand Name
Physical Sunscreen SPF50 80 min WR 159-100
Generic Name
titanium dioxide, titanium dioxide sunscreen
NDC Code (Product)
60232-0044
Manufacturer
Swiss-American CDMO, LLC
Strength
42.3 g/1000g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
11/09/2023

Recall History

No Recall History

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 measure (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. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Physical Sunscreen SPF50 80 min WR 159-100 used for?

Physical Sunscreen SPF50 80 min WR 159-100 contains titanium dioxide, titanium dioxide sunscreen. It is a lotion taken topical. Consult your doctor for specific uses.

Is Physical Sunscreen SPF50 80 min WR 159-100 a controlled substance?

Physical Sunscreen SPF50 80 min WR 159-100 is not classified as a controlled substance by the DEA.

What is the generic name for Physical Sunscreen SPF50 80 min WR 159-100?

The generic name for Physical Sunscreen SPF50 80 min WR 159-100 is titanium dioxide, titanium dioxide sunscreen. There are no other listed brand versions of titanium dioxide, titanium dioxide sunscreen.

What is the NDC code for Physical Sunscreen SPF50 80 min WR 159-100 42.3 g/1000g?

The NDC (National Drug Code) for Physical Sunscreen SPF50 80 min WR 159-100 42.3 g/1000g is 60232-0044, listed by Swiss-American CDMO, LLC.

Product NDC

60232-0044

Package NDC

60232-0044-1

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

Data from openFDA · Public domain (CC0 1.0)