FDA.reportPublic FDA data

Procedure Enhancement System

Manufacturer
Alastin Skincare, Inc.
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:12

Label at a glance#

ProductProcedure Enhancement System
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.95%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • 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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70604-030-02Procedure Enhancement System53.8 g in 1 TUBECREAM53.8 g0.1995 g in 1g2
70604-040-00Procedure Enhancement System1 in 1 BAGKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70604-030PROCEDURE ENHANCEMENT SYSTEM (ZINC OXIDE) KIT [ALASTIN SKINCARE, INC.]2Legacy NDC20240202_8243d68a-a382-4e5c-901b-371180de1391.zip
70604-040PROCEDURE ENHANCEMENT SYSTEM (ZINC OXIDE) KIT [ALASTIN SKINCARE, INC.]22 package rows20240202_8243d68a-a382-4e5c-901b-371180de1391.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 69 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70604-04070604-040-00
70604-03070604-030-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 102 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
GLYCERINPDC6A3C0OXINGR
CETEARYL METHICONE (15000 MW)VY9RTR7MSYINGR
DIMETHICONE92RU3N3Y1OINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYINGR
POLYACRYLATE-13FS2D4T67EAINGR
PHENOXYETHANOLHIE492ZZ3TINGR
POLYISOBUTYLENE (1000 MW)5XB3A63Y52INGR
POTASSIUM HYDROLYZED JOJOBA ESTERSCH428W5O62INGR
PANTHENOLWV9CM0O67ZINGR
CAPRYLYL GLYCOL00YIU5438UINGR
SOY STEROLPL360EPO9JINGR
LINOLEIC ACID9KJL21T0QJINGR
LECITHIN, SOYBEAN1DI56QDM62INGR
XANTHAN GUMTTV12P4NEEINGR
GLYCERYL MONOOLEATEC4YAD5F5G6INGR
STEARYL GLYCYRRHETINATE3YYE6VJS0PINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
BETAINE3SCV180C9WINGR
CAPRYLHYDROXAMIC ACIDUPY805K99WINGR
POLYSORBATE 207T1F30V5YHINGR
SORBITAN ISOSTEARATE01S2G2C1E4INGR
POTASSIUM SORBATE1VPU26JZZ4INGR
SODIUM BENZOATEOJ245FE5EUINGR
BENZYL ALCOHOLLKG8494WBHINGR
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GINGR
ANHYDROUS CITRIC ACIDXF417D3PSLINGR
.GAMMA.-TOCOPHEROL8EF1Z1238FINGR
CYCLOMETHICONE 50THT5PCI0RINGR
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6INGR
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FINGR
HEPTYL UNDECYLENATEW77QUB6GXOINGR
SOYBEAN OIL241ATL177AINGR
PANTHENOL TRIACETATE, (+)-1206E8961BINGR
SQUALANEGW89575KF9INGR
CAPRYLYL TRISILOXANEQ95M2P1KJLINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ccb56680-ef47-41f3-9fa8-278ea06962d68243d68a-a382-4e5c-901b-371180de13912024-01-24WarningsExact identifier
spl id: ccb56680-ef47-41f3-9fa8-278ea06962d6
spl set id: 8243d68a-a382-4e5c-901b-371180de1391

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.