YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen 21 g/100g

Zinc Oxide · LOTION · CA-Botana International

No Recall History

Plain English

YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen is a lotion containing zinc oxide at 21 g/100g, taken topical. Manufactured by CA-Botana International.

Key Facts

Brand Name: YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen
Generic Name: Zinc Oxide
NDC Code (Product): 35192-100
Manufacturer: CA-Botana International
Strength: 21 g/100g
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 03/20/2026

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 YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen used for?

YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen contains Zinc Oxide. It is a lotion taken topical. Consult your doctor for specific uses.

Is YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen a controlled substance?

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

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

The generic name for YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen 21 g/100g?

The NDC (National Drug Code) for YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen 21 g/100g is 35192-100, listed by CA-Botana International.

Product NDC

35192-100

Package NDC

35192-100-00

Other Zinc Brands

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

Data from openFDA · Public domain (CC0 1.0)