Zo® Skin Health Broad-spectrum Sunscreen Spf 50

Zo® Skin Health Broad-spectrum Sunscreen Spf 50
SPL v4
SPL
SPL Set ID d817f80b-a998-b67e-e053-2995a90a1971
Route
TOPICAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (7.552 mg) Zinc Oxide (17.7 mg)
Inactive Ingredients
Phenoxyethanol Silicon Dioxide 1,2-hexanediol Aluminum Oxide Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Erythritol Ethylhexylglycerin Hexyl Laurate Glycyrrhiza Uralensis Root Butylene Glycol Glycerin Ascorbic Acid Calcium Chloride Dimethicone Homarine Hydrochloride Polyglyceryl-4 Isostearate Vitamin A Palmitate Solanum Anomalum Whole Sodium C14-16 Olefin Sulfonate Sodium Chloride Sodium Citrate Sodium Benzoate Poly(methyl Methacrylate; 450000 Mw) Potassium Sorbate Ferric Oxide Red Scutellaria Lateriflora Top Stearic Acid Squalane .alpha.-tocopherol Acetate Levomenol Pentylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Tribehenin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-15

Description

Active Ingredient Purpose Titanium Dioxide 6.4% Sunscreen Zinc Oxide 15.0% Sunscreen


Medication Information

Description

Active Ingredient Purpose Titanium Dioxide 6.4% Sunscreen Zinc Oxide 15.0% Sunscreen

Uses
  • Helps prevent sunburn
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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.
Do Not Use
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredient Purpose
Titanium Dioxide 6.4% Sunscreen
Zinc Oxide 15.0% Sunscreen

Outer Package Label

ZO® Skin Health

by ZEIN OBAGI MD

NDC 42851-064-04

BROAD-SPECTRUM

SUNSCREEN SPF 50


For sensitized skin

ZOX 12®

Lightweight, non-irritating mineral sunscreen for the most sensitive skin types and post-procedure skin. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX 12®

Engineered with our exclusive 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com

Inactive Ingredients

1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, Calcium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Cordyceps Militaris Mycelium Extract, Dimethicone, Dimethicone Crosspolymer, Erythritol, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Hexyl Laurate, Homarine HCL, Iron Oxides, Lactobacillus Ferment, Melanin, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethyl Methacrylate, Potassium Sorbate, Retinyl Palmitate, Scutellaria Baicalensis Root Extract, Silica, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Tocopheryl Acetate, Tribehenin.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
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.

Structured Label Content

Uses
  • Helps prevent sunburn
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredient Purpose
Titanium Dioxide 6.4% Sunscreen
Zinc Oxide 15.0% Sunscreen

Outer Package Label

ZO® Skin Health

by ZEIN OBAGI MD

NDC 42851-064-04

BROAD-SPECTRUM

SUNSCREEN SPF 50


For sensitized skin

ZOX 12®

Lightweight, non-irritating mineral sunscreen for the most sensitive skin types and post-procedure skin. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX 12®

Engineered with our exclusive 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com

Inactive Ingredients

1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, Calcium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Cordyceps Militaris Mycelium Extract, Dimethicone, Dimethicone Crosspolymer, Erythritol, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean) Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Hexyl Laurate, Homarine HCL, Iron Oxides, Lactobacillus Ferment, Melanin, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethyl Methacrylate, Potassium Sorbate, Retinyl Palmitate, Scutellaria Baicalensis Root Extract, Silica, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Tocopheryl Acetate, Tribehenin.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
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.

Advanced Ingredient Data


Raw Label Data

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