Zo Skin Health Sunscreen Plus Primer Broad-spectrum Spf 30 Cream
FDA Label NDC 42851-060

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 Sunscreen Plus Primer Broad-spectrum Spf 30 (NDC 42851-060). 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, do not use, when using this product, stop use and ask a doctor if, 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 1.0%Sunscreen
Zinc Oxide 20.0%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 or irritation develops and lasts.

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 and as needed.
  • 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.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Leaf Extract, Ecklonia Kurome Extract, Glycine Soja (Soybean) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hexyl Laurate, Polyglyceryl-4 Isostearate, Tribehenin, Bisabolol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Glycerin, Squalane, Polymethyl Methacrylate, Dimethiconol, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Caprylyl Glycol, Behenyl Behenate, Melanin, Tocopheryl Acetate, Ethyl Ferulate, Polyglyceryl-5 Trioleate, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Disodium Uridine Phosphate, Ethylhexylglycerin, Tocopherol, Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

Principal Display Panel - 30 Ml Bottle Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-060-30

SUNSCREEN + PRIMER
BROAD-SPECTRUM
SPF 30

ZOX12™

30 mL / 1 Fl. Oz.

* Please review the disclaimer below.