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Drug Facts
Dist. by: MD Medical Designs, Inc.
Beverly Hills, CA 90210
Skinuva Scar Plus Cream
FDA Label NDC 82350-352
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Md Medical Designs, Inc. for the product Skinuva Scar Plus (NDC 82350-352). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose Data on file |
|---|---|
| Zinc Oxide 10% | Sunscreen |
| Dosage Form | Cream |
Uses
Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged/broken skin or open wounds.
Otc - When Using
When using this product keep out of eyes. If contact occurs, rinse eyes thoroughly with plenty of water to remove. If swallowed immediately seek medical advice and show container or label.
Otc - Stop Use
Stop use and ask a doctor if rash or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Make sure the affected area is clean and dry. Apply a thin film over the affected area twice a day, morning and night. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. See insert for detailed instructions.
Other Information
Do not use if inner seal is broken. Store at room temperature. Avoid excessive heat.
Inactive Ingredients
Water/Aqua, Dimethicone, Dimethiconol, Cyclopentasiloxane, Dimethicone Crosspolymer, Butylene Glycol, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone/PEG-10/15 Crosspolymer, Tetrahexyldecyl Ascorbate, Centella Asiatica Extract, Diphenylsiloxy Phenyl Trimethicone, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, sh-Polypeptide-1, Tocopherol, sh-Polypeptide-6, sh-Polypeptide-5
Principal Display Panel - 30 Ml Bottle Carton
NDC: 82350-352-30
SKINUVA®
scar+
BROAD SPECTRUM SPF 30
Scar photoaging defense cream using
highly selective growth factors with
Zinc Oxide mineral sunscreen
Developed and tested
by physicians
30 mL / 1 fl. oz e
Principal Display Panel (30 mL Bottle Carton)
* Please review the disclaimer below.
