Zo ®

Zo ®
SPL v2
SPL
SPL Set ID 92dc0786-083b-4c5a-8bea-dc2d5a391b10
Route
TOPICAL
Published
Effective Date 2019-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (20 mg)
Inactive Ingredients
Water Ascorbic Acid Ascorbyl Palmitate Caprylyl Glycol Cetyl Alcohol Chlorphenesin Dioscorea Villosa Tuber Edetate Disodium Anhydrous Ethylhexyl Palmitate Glycerin Glycolic Acid Palmitic Acid Phenoxyethanol Phenyl Trimethicone Quillaja Saponaria Bark Smilax Aristolochiifolia Root Sodium Hydroxide Sodium Lauryl Sulfate Sodium Metabisulfite Sodium Sulfite Stearyl Alcohol .alpha.-tocopherol Acetate Yucca Schidigera Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2019-01-11 Until 2020-09-23

Description

Drug Facts

Purpose

Skin Lightener


Medication Information

Purpose

Skin Lightener

Description

Drug Facts

Uses

For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Section 50566-9

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Section 50570-1

Do not use on children under 12 years of age unless directed by a doctor.

Warnings

For external use only.

Avoid contact with eyes.

Directions
  • Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Questions?

5 Technology Dr. Irvine, CA 92618

Active Ingredient

Hydroquinone, 2%

Other Information
  • Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Inactive Ingredients

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract

Principal Display Panel 80 Ml Bottle Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-039-80

PIGMENT CONTROL +

BLENDING CRÈME

2% Hydroquinone

80 mL / 2.7 Fl. Oz.


Structured Label Content

Uses

For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Section 50570-1 (50570-1)

Do not use on children under 12 years of age unless directed by a doctor.

Purpose

Skin Lightener

Warnings

For external use only.

Avoid contact with eyes.

Directions
  • Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Questions?

5 Technology Dr. Irvine, CA 92618

Active Ingredient

Hydroquinone, 2%

Other Information
  • Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Inactive Ingredients

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract

Principal Display Panel 80 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton)

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-039-80

PIGMENT CONTROL +

BLENDING CRÈME

2% Hydroquinone

80 mL / 2.7 Fl. Oz.


Advanced Ingredient Data


Raw Label Data

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