Zo Skin Health Renew
FDA Label NDC 42851-163

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 Renew (NDC 42851-163). 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, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

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

Active Ingredients

Titanium Dioxide 8.2%

Purpose

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.

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

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
  • children under 6 months of age: ask a doctor
  • reapply at least every two hours
  • 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
  • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive Ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Water, Helianthus Annuus (Sunflower) Seed Oil, Polymethyl Methacrylate, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Dimethiconol, Cyclotetrasiloxane, Squalane, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Melanin, Behenyl Behenate, Triethoxycaprylylsilane, Polyglyceryl-5 Trioleate, Ethyl Ferulate, Glycine Soja (Soybean) Seed Extract, Calcium Chloride, Retinyl Palmitate, Pentylene Glycol, Methylisothiazolinone, Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phenoxyethanol, Potassium Sorbate, Ethylhexylglycerin, Myristoyl Pentapeptide-8, Tocopherol, Disodium Uridine Phosphate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Iron Oxides.

Principal Display Panel - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

RENEW

OFFECTS® HYDRATING CLEANSER
40 mL / 1.5 Fl. Oz.

OFFECTS® EXFOLIATING POLISH
Net Wt. 16.2 g / 0.57 Oz.

OCLIPSE® SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
15 mL / 0.5 Fl. Oz.

NDC 42851-163-01

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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