Sunceutical SPF 50 Mineral Body Cream 20 g/100mL

Zinc Oxide · CREAM · Baxter Laboratories Pty. Ltd.

No Recall History

Plain English

Sunceutical SPF 50 Mineral Body Cream is a cream containing zinc oxide at 20 g/100mL, taken topical. Manufactured by Baxter Laboratories Pty. Ltd..

Key Facts

Brand Name: Sunceutical SPF 50 Mineral Body Cream
Generic Name: Zinc Oxide
NDC Code (Product): 70157-368
Manufacturer: Baxter Laboratories Pty. Ltd.
Strength: 20 g/100mL
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 01/20/2025

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

Stop use and ask a doctor if rash occurs.

Dosage & Administration

Directions Apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor 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 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 Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating

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.

Frequently Asked Questions

What is Sunceutical SPF 50 Mineral Body Cream used for?

Sunceutical SPF 50 Mineral Body Cream contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is Sunceutical SPF 50 Mineral Body Cream a controlled substance?

Sunceutical SPF 50 Mineral Body Cream is not classified as a controlled substance by the DEA.

What is the generic name for Sunceutical SPF 50 Mineral Body Cream?

The generic name for Sunceutical SPF 50 Mineral Body Cream is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for Sunceutical SPF 50 Mineral Body Cream 20 g/100mL?

The NDC (National Drug Code) for Sunceutical SPF 50 Mineral Body Cream 20 g/100mL is 70157-368, listed by Baxter Laboratories Pty. Ltd..

Product NDC

70157-368

Package NDC

70157-368-02

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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)