Active Ingredients
| Active Ingredients | Purpose |
| Salicylic Acid 2.0% | Acne Medication |
Zo Skin Health Retinol Plus Acne Complex Lotion
FDA Label NDC 42851-093
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Zo Skin Health Retinol Plus Acne Complex (NDC 42851-093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, other safety information, when using this product, stop use and ask a doctor, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- For the management of acne.
- Penetrates pores to control acne blemishes.
- Helps prevent new acne blemishes from forming.
Other Safety Information
For external use only.
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.
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.
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
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