Zo Skin Health
FDA Label NDC 42851-155

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Zo Skin Health (NDC 42851-155). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

Otc - Purpose

Active ingredientsPurpose
Titanium Dioxide 10.2%Sunscreen
Zinc Oxide 3.7%Sunscreen

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.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop and ask a doctor if rash occurs.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

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
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: 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.
    • Apply to all skin exposed to the sun

Other Information

  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

Inactive Ingredients

Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).

Principal Display Panel - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI, MD

OSSENTIAL®
DAILY POWER DEFENSE
ANTI-AGING FORMULA
+
OCLIPSE®
SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
UVA/UVB PROTECTION

NDC 42851-155-03

beverly hills

ANTI-AGING COMBO PACK

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

* Please review the disclaimer below.