Zo® Skin Health Retinol + Acne Complex (formula No. Zo-012-10)

Zo® Skin Health Retinol + Acne Complex (formula No. Zo-012-10)
SPL v2
SPL
SPL Set ID 1d65e4d2-0856-9135-e063-6294a90a5c66
Route
TOPICAL
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 mg)
Inactive Ingredients
Aminomethylpropanol Bakuchiol Cocamidopropyl Dimethylamine Retinol Olive Oil Potassium Azeloyl Diglycinate Sodium Bisulfite Isohexadecane Butylated Hydroxytoluene Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Ethylhexylglycerin Dimethicone, Unspecified Lecithin, Sunflower Caprylhydroxamic Acid Sodium Sulfate Cetyl Glyceryl Ether Propanediol Rosa Canina Fruit Water Silicon Dioxide Betasizofiran Sodium Metabisulfite Polysorbate 20 Butylene Glycol Edetate Disodium Phenoxyethanol Glycerin Polysorbate 80 Sodium Sulfite Safflower Seed Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-12

Description

Active Ingredients Purpose Salicylic Acid 2.0% Acne Medication


Medication Information

Description

Active Ingredients Purpose Salicylic Acid 2.0% Acne Medication

Uses
  • For the management of acne.
  • Penetrates pores to control acne blemishes.
  • Helps prevent new acne blemishes from forming.
Section 60561-8

For external use only.

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Salicylic Acid 2.0% Acne Medication

Inactive Ingredients

Water, Cocamidopropyl Dimethylamine, Glycerin,

Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl

Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate

Mesylate, Carthamus Tinctorius (Safflower) Seed

Oil, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit

Extract, Leontopodium Alpinum Meristem Cell

Culture, Marrubium Vulgare Meristem Cell Culture,

Lecithin, Propanediol, Potassium Azeloyl

Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl

Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium

Metabisulfite, Sodium Sulfite, Sodium Sulfate,

Polysorbate 20, Acrylamide/Sodium

Acryloyldimethyltaurate Copolymer, Butylene Glycol,

Isohexadecane, Bakuchiol, Aminomethyl Propanol,

Caprylhydroxamic Acid, Disodium EDTA,

Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI, MD

NDC 42851-093-50

RETINOL + ACNE COMPLEX

50 mL / 1.7 Fl. Oz.

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

Made in USA with US & imported materials

zoskinhealth.com | 917200

When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one topical acne medication at a time.
Stop Use and Ask A Doctor
  • if irritation occurs or gets worse.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses
  • For the management of acne.
  • Penetrates pores to control acne blemishes.
  • Helps prevent new acne blemishes from forming.
Section 60561-8 (60561-8)

For external use only.

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Information
  • Protect this product from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Salicylic Acid 2.0% Acne Medication

Inactive Ingredients

Water, Cocamidopropyl Dimethylamine, Glycerin,

Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl

Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate

Mesylate, Carthamus Tinctorius (Safflower) Seed

Oil, Olea Europaea (Olive) Fruit Oil, Rosa Canina Fruit

Extract, Leontopodium Alpinum Meristem Cell

Culture, Marrubium Vulgare Meristem Cell Culture,

Lecithin, Propanediol, Potassium Azeloyl

Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl

Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium

Metabisulfite, Sodium Sulfite, Sodium Sulfate,

Polysorbate 20, Acrylamide/Sodium

Acryloyldimethyltaurate Copolymer, Butylene Glycol,

Isohexadecane, Bakuchiol, Aminomethyl Propanol,

Caprylhydroxamic Acid, Disodium EDTA,

Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI, MD

NDC 42851-093-50

RETINOL + ACNE COMPLEX

50 mL / 1.7 Fl. Oz.

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

Made in USA with US & imported materials

zoskinhealth.com | 917200

When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one topical acne medication at a time.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if irritation occurs or gets worse.
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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