FDA Label for Procedure Enhancement System

View Indications, Usage & Precautions

Procedure Enhancement System Product Label

The following document was submitted to the FDA by the labeler of this product Alastin Skincare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by Alastin Skincare®, Inc., a Galderma Company
Carlsbad, CA 92010


Active Ingredients



Zinc Oxide 19.95%


Purpose



Sunscreen


Uses



  • Helps prevent sunburn

Warnings



  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every two hours
    • 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 10am - 2pm
      • Wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients



Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate


Other Information



  • Protect the product in this container from excessive heat and direct sun.
    Store at room temperature 15° - 30°C (59° - 86°F).

Principal Display Panel - Kit Carton



074A

ALASTIN®
SKINCARE

PROCEDURE
ENHANCEMENT
SYSTEM

with TriHex Technology®

Expertly formulated to complement in-office cosmetic treatments by enhancing
results and accelerating recovery. Ideal for sensitive and post-procedure skin.


* Please review the disclaimer below.