ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) .675 mg/g

Zinc Oxide · POWDER · ZO Skin Health, Inc.

No Recall History

Plain English

ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) is a prescription powder containing zinc oxide at .675 mg/g, taken topical. Manufactured by ZO Skin Health, Inc..

Key Facts

Brand Name: ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)
Generic Name: Zinc Oxide
NDC Code (Product): 42851-049
Manufacturer: ZO Skin Health, Inc.
Strength: .675 mg/g
Dosage Form: POWDER
Route: TOPICAL
Marketing Status: HUMAN OTC DRUG
Application #: M020
Marketing Start: 02/09/2021

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 Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against 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 ■ 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. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. ■ Protect the product in this container from excessive heat and direct sun. ■ You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618

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 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 ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) used for?

ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) contains Zinc Oxide. It is a powder taken topical. Consult your doctor for specific uses.

Is ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) a controlled substance?

ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) is not classified as a controlled substance by the DEA.

What is the generic name for ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)?

The generic name for ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.

What is the NDC code for ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) .675 mg/g?

The NDC (National Drug Code) for ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) .675 mg/g is 42851-049, listed by ZO Skin Health, Inc..

Product NDC

42851-049

Package NDC

42851-049-27

Other Zinc Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)