FDA.reportPublic FDA data

Obagi-C Fx System Normal-Oily

Manufacturer
Obagi Cosmeceuticals LLC | Universal Packaging Systems, Inc. DBA: PakLab | Swiss American CDMO, LLC | Bay Cities Container Corporation
Effective date
2019-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:42

Label at a glance#

ProductObagi-C Fx System Normal-Oily Skin Brightening System With Arbutin
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
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 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 ...

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
Homosalate 10%Sunscreen
Octisalate 5%Sunscreen
Zinc Oxide 16.5%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
  • 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
  • children under 6 months: Ask a doctor

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

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 Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

OBAGI-C® FX SYSTEM

NORMAL OILY

Skin Brightening System
with Arbutin

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-536-572021-07-23C16284748780-1c7ccaba7-248a-fd44-e053-dadaa90aa01bOBAGI-C ® FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-142-11Obagi-C Fx System Normal-Oily Skin Brightening System With Arbutin85 g in 1 TUBELOTION85 g50 mg in 1g1
62032-536-57Obagi-C Fx System Normal-Oily Skin Brightening System With Arbutin1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-142OBAGI-C FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN (HOMOSALATE, OCTISALATE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]1Unmatched20191202_3884e73d-7e5e-4b54-8cc6-4d5904a38246.zip
62032-536OBAGI-C FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN (HOMOSALATE, OCTISALATE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]1Legacy NDC, 2 package rows20191202_3884e73d-7e5e-4b54-8cc6-4d5904a38246.zip

Products#

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

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-53662032-536-57
62032-14262032-142-11

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 77 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3INGR
WATER059QF0KO0RINGR
ASCORBIC ACIDPQ6CK8PD0RINGR
SODIUM LAURYL SULFATE368GB5141JINGR
PROPYLENE CARBONATE8D08K3S51EINGR
ALCOHOL3K9958V90MINGR
DIPROPYLENE GLYCOLE107L85C40INGR
ARBUTINC5INA23HXFINGR
EDETATE DISODIUM7FLD91C86KINGR
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AINGR
TROLAMINE SALICYLATEH8O4040BHDINGR
SODIUM LAURYL SULFATE368GB5141JINGR
CETYL ALCOHOL936JST6JCNINGR
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
ASCORBIC ACIDPQ6CK8PD0RINGR
SODIUM METABISULFITE4VON5FNS3CINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
BUTYLATED HYDROXYTOLUENE1P9D0Z171KINGR
PHENYL TRIMETHICONEDR0K5NOJ4RINGR
GLYCERINPDC6A3C0OXINGR
WATER059QF0KO0RINGR
ARBUTINC5INA23HXFINGR
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HydroxyacetophenoneG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
Sodium Chloride451W47IQ8XIACT
Sodium Hydroxide55X04QC32IIACT
Octyldodecyl NeopentanoateX8725R883TIACT
TriethoxycaprylylsilaneLDC331P08EIACT
C15-19 AlkaneCI87N1IM01IACT
Disteardimonium HectoriteX687XDK09LIACT
POLYGLYCERYL-2 MONOISOSTEARATE7B8OE71MQCIACT
Sorbitan OlivateMDL271E3GRIACT
DIMETHICONE92RU3N3Y1OIACT

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
65930ec0-7af1-4af8-a22f-34149c6fb7c63884e73d-7e5e-4b54-8cc6-4d5904a382462019-10-29WarningsExact identifier
spl id: 65930ec0-7af1-4af8-a22f-34149c6fb7c6
spl set id: 3884e73d-7e5e-4b54-8cc6-4d5904a38246

Reported adverse events (FAERS/openFDA)#

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