Drugplain

Broad Spectrum SPF 50 Mineral Sunscreen 100 mg/mL

TITANIUM DIOXIDE, ZINC OXIDE · CREAM · Aruba Aloe Balm NV

No Recall History
Plain English

Broad Spectrum SPF 50 Mineral Sunscreen is a cream containing titanium dioxide, zinc oxide at 100 mg/mL, taken topical. Manufactured by Aruba Aloe Balm NV.

Key Facts

Brand Name
Broad Spectrum SPF 50 Mineral Sunscreen
Generic Name
TITANIUM DIOXIDE, ZINC OXIDE
NDC Code (Product)
53675-189
Manufacturer
Aruba Aloe Balm NV
Strength
100 mg/mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
06/15/2020

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

Uses 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

Directions Directions Apply liberally and evenly 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 int he 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 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. children under 6 months of age: ask a doctor

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 Broad Spectrum SPF 50 Mineral Sunscreen used for?

Broad Spectrum SPF 50 Mineral Sunscreen contains TITANIUM DIOXIDE, ZINC OXIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is Broad Spectrum SPF 50 Mineral Sunscreen a controlled substance?

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

What is the generic name for Broad Spectrum SPF 50 Mineral Sunscreen?

The generic name for Broad Spectrum SPF 50 Mineral Sunscreen is TITANIUM DIOXIDE, ZINC OXIDE. There are 12 other brand versions of TITANIUM DIOXIDE, ZINC OXIDE.

What is the NDC code for Broad Spectrum SPF 50 Mineral Sunscreen 100 mg/mL?

The NDC (National Drug Code) for Broad Spectrum SPF 50 Mineral Sunscreen 100 mg/mL is 53675-189, listed by Aruba Aloe Balm NV.