Zo ®

Zo ®
SPL v8
SPL
SPL Set ID 9a4f5be1-da04-48b9-897a-57f4a3d9d1ec
Route
TOPICAL
Published
Effective Date 2019-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (10 mg) Zinc Oxide (200 mg)
Inactive Ingredients
Soybean Rosemary Hexyl Laurate Polyglyceryl-4 Isostearate Tribehenin Water Glycerin Squalane Alpha-tocopherol Acetate Stearic Acid Caprylyl Glycol Behenyl Behenate Ethyl Ferulate Triethoxycaprylylsilane Ascorbic Acid Vitamin A Palmitate Ethylhexylglycerin Tocopherol Pentylene Glycol Phenoxyethanol Chlorphenesin Cyclomethicone 5 Levomenol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Ferric Oxide Red Aluminum Oxide Medium-chain Triglycerides Dimethicone Peg-10 Dimethicone (600 Cst) Phenyl Trimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Glycyrrhiza Uralensis Sunflower Oil Centella Asiatica Leaf Ecklonia Kurome

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-31
Description

Drug Facts

Medication Information

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 55105-1
Active Ingredients Purpose
Titanium Dioxide 1.0% Sunscreen
Zinc Oxide 20.0% Sunscreen
Warnings

For external use only.

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.
Do Not Use
  • on damaged or broken skin.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone,Dimethicone/Vinyl DimethiconeCrosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica 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, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Ethylhexylglycerin, Tocopherol,

Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Changes To: Uses, Directions

Addition of: 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

Changed formatting of Directions.

Stop Use and Ask A Doctor If
  • rash occurs.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel 30 Ml Bottle Carton

ZO ® SKIN HEALTH







BY ZEIN OBAGI MD

NDC 42851-060-30

SUNSCREEN + PRIMER







BROAD-SPECTRUM







SPF 30

ZOX 12 ™

30 mL / 1 Fl. Oz.

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 55105-1 (55105-1)
Active Ingredients Purpose
Titanium Dioxide 1.0% Sunscreen
Zinc Oxide 20.0% Sunscreen
Warnings

For external use only.

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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone,Dimethicone/Vinyl DimethiconeCrosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica 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, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Ethylhexylglycerin, Tocopherol,

Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Changes To: Uses, Directions (Changes to: Uses, Directions)

Addition of: 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

Changed formatting of Directions.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
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.
Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

ZO ® SKIN HEALTH







BY ZEIN OBAGI MD

NDC 42851-060-30

SUNSCREEN + PRIMER







BROAD-SPECTRUM







SPF 30

ZOX 12 ™

30 mL / 1 Fl. Oz.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:07.286166 · Updated: 2026-03-14T23:04:37.184149