FDA.reportPublic FDA data

GENTLE REJUVENATION SYSTEM

Manufacturer
Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. | LABORATOIRE DR RENAUD INC. | Swiss-American CDMO, LLC
Effective date
2017-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:32

Label at a glance#

ProductGENTLE REJUVENATION SYSTEM
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: 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 measur...

Storage and handling

• store at controlled room temperature: 15°C–25°C (59°F–77°F) • protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose

Avobenzone 3%

Sunscreen

Homosalate 8%

Sunscreen

Octisalate 5%

Sunscreen

Octocrylene 2.79%

Sunscreen

Oxybenzone 3%

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: 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 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-10

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by OMP, Inc., Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®

MEDICAL

GENTLE REJUVENATION SYSTEM

Sensitive Skin Kit

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-525-912020-01-31C16284748780-19d75b9d0-41dd-f424-e053-dadaa90a57ceGENTLE REJUVENATION SYSTEM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-130-70GENTLE REJUVENATION SYSTEM48 g in 1 BOTTLECREAM48 g80 mg in 1g2
62032-525-91GENTLE REJUVENATION SYSTEM1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-130GENTLE REJUVENATION SYSTEM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) KIT [OBAGI MEDICAL PRODUCTS, INC., A DIVISION OF VALEANT PHARMACEUTCALS NORTH AMERICA LLC.]2Legacy NDC20171219_d1cd71bd-1e87-4aa9-9eee-ddb4d1274b8d.zip
62032-525GENTLE REJUVENATION SYSTEM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) KIT [OBAGI MEDICAL PRODUCTS, INC., A DIVISION OF VALEANT PHARMACEUTCALS NORTH AMERICA LLC.]2Legacy NDC, 2 package rows20171219_d1cd71bd-1e87-4aa9-9eee-ddb4d1274b8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CITRUS MAXIMA FRUIT RINDINACTIVE INGREDIENT5NX3G75CA61
DIMETHICONE 100INACTIVE INGREDIENTRO266O364U1
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QS1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-52562032-525-91
62032-13062032-130-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRUS MAXIMA FRUIT RIND5NX3G75CA6IACT
DIMETHICONE 100RO266O364UIACT
OCTOXYNOL-97JPC6Y25QSIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 31 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
DIMETHICONE 100DIMETHICONE 100RO266O364UGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAMUSCULAR192 mgExact identifier — unii candidate
25 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSGEL / TOPICAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, DELAYED RELEASE / ORAL12 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RPOWDER, FOR SOLUTION / ORAL560 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE / ORAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
DIMETHICONE 100DIMETHICONE 100RO266O364UTABLET, FILM COATED / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION / ORAL520 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRACAVITARY5 mgExact identifier — unii candidate
25 equally ranked IID candidates
DIMETHICONE 100DIMETHICONE 100RO266O364UCAPSULE / ORAL4 mgExact identifier — unii candidate
3 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSLOTION / TOPICAL5 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
49464cf1-72f1-458d-ae9d-d1a3de636623d1cd71bd-1e87-4aa9-9eee-ddb4d1274b8d2017-12-19WarningsExact identifier
spl id: 49464cf1-72f1-458d-ae9d-d1a3de636623
spl set id: d1cd71bd-1e87-4aa9-9eee-ddb4d1274b8d

Reported adverse events (FAERS/openFDA)#

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