Procedure Enhancement System
FDA Label NDC 70604-040

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alastin Skincare, Inc. for the product Procedure Enhancement System (NDC 70604-040). 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, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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