Zo®

Zo®
SPL v1
SPL
SPL Set ID 73246324-eede-4933-9921-bb2b59642964
Route
TOPICAL
Published
Effective Date 2016-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.08 g)
Inactive Ingredients
Water Aluminum Hydroxide Stearic Acid Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cyclomethicone 5 Phenyl Trimethicone Pentylene Glycol Dimethicone Glycerin Isodecyl Neopentanoate Diisopropyl Sebacate Lauryl Lactate Edetate Disodium Phytosphingosine Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Peg-100 Stearate Glyceryl Monostearate Sodium Dihydroxycetyl Phosphate Hydrogenated Palm Glycerides Melanin Synthetic (tyrosine, Peroxide) Ethylhexylglycerin Erythritol Homarine Hydrochloride Sodium Benzoate Potassium Sorbate Phenoxyethanol Caprylyl Glycol Chlorphenesin Nephelium Lappaceum Fruit Rind Soybean Silicon Dioxide C13-14 Isoparaffin Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-11-01
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

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.
Active Ingredient

Titanium Dioxide 8%

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
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

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

For external use only.

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.
Active Ingredient (Active ingredient)

Titanium Dioxide 8%

Other Information (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
Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL - Kit Carton)

ZO® MEDICAL

BY ZEIN OBAGI MD

NDC 42851-158-60

ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Skin Brightening

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.602367 · Updated: 2026-03-14T22:54:22.435915