ZO Skin Health Broad-Spectrum Sunscreen SPF 50 7.552 mg/118g

Titanium Dioxide, Zinc Oxide · CREAM · ZO Skin Health, Inc.

No Recall History

Plain English

ZO Skin Health Broad-Spectrum Sunscreen SPF 50 is a prescription cream containing titanium dioxide, zinc oxide at 7.552 mg/118g, taken topical. Manufactured by ZO Skin Health, Inc..

Key Facts

Brand Name: ZO Skin Health Broad-Spectrum Sunscreen SPF 50
Generic Name: Titanium Dioxide, Zinc Oxide
NDC Code (Product): 42851-064
Manufacturer: ZO Skin Health, Inc.
Strength: 7.552 mg/118g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status: HUMAN OTC DRUG
Application #: M020
Marketing Start: 08/15/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

application site acne1 reports

application site hypersensitivity1 reports

application site vesicles1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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.

Dosage & Administration

Drug Facts Active Ingredients Active Ingredient Purpose Titanium Dioxide 6.4% Sunscreen Zinc Oxide 15.0% Sunscreen Uses Helps prevent sunburn 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. Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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. Other Information Protect the product in this container from excessive heat and direct sun. Inactive Ingredients 1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, C…

Warnings

Warnings For external use only.

Frequently Asked Questions

What is ZO Skin Health Broad-Spectrum Sunscreen SPF 50 used for?

ZO Skin Health Broad-Spectrum Sunscreen SPF 50 contains Titanium Dioxide, Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.

Is ZO Skin Health Broad-Spectrum Sunscreen SPF 50 a controlled substance?

ZO Skin Health Broad-Spectrum Sunscreen SPF 50 is not classified as a controlled substance by the DEA.

What is the generic name for ZO Skin Health Broad-Spectrum Sunscreen SPF 50?

The generic name for ZO Skin Health Broad-Spectrum Sunscreen SPF 50 is Titanium Dioxide, Zinc Oxide. There are 12 other brand versions of Titanium Dioxide, Zinc Oxide.

What is the NDC code for ZO Skin Health Broad-Spectrum Sunscreen SPF 50 7.552 mg/118g?

The NDC (National Drug Code) for ZO Skin Health Broad-Spectrum Sunscreen SPF 50 7.552 mg/118g is 42851-064, listed by ZO Skin Health, Inc..

Product NDC

42851-064

Package NDC

42851-064-04

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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)