Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening
FDA Label NDC 42851-158

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 Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening (NDC 42851-158). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, 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

Active Ingredient

Titanium Dioxide 8%

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.

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.

Other Information

  • Store product in a cool place away from direct heat and sunlight.
  • You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618

Directions

  • For full protection, apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • For 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.
    • Apply to all skin exposed to the sun.

Inactive Ingredients

Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja (Soybean) extract, Silica, C13-14 Isoparaffin, Laureth-7.

Principal Display Panel - Kit Carton

ZO® MEDICAL
BY ZEIN OBAGI MD

NDC 42851-158-60

ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Skin Brightening

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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