FDA.reportPublic FDA data

Obagi Nu-Derm FX System Normal - Oily

Manufacturer
Obagi Cosmeceuticals LLC | Swiss-American CDMO, LLC | G. S. Cosmeceutical USA, Inc.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:29

Label at a glance#

ProductObagi Nu-Derm FX System Normal - Oily Skin Transformation Complexion Brightening System
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 NU-DERM FX™
SYSTEM

NORMAL OILY

Skin Transformation Kit
Complexion Brightening System

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-538-912025-04-03C16284748780-12cef2736-b138-d83d-e063-dadaa90ab31fObagi ® Nu-Derm FX™ System Normal - Oily Skin Transformation Kit Complexion Brightening System
62032-538-912025-01-30C16284748780-12cef2736-b138-d83d-e063-dadaa90ab31fObagi ® Nu-Derm FX™ System Normal - Oily Skin Transformation Kit Complexion Brightening System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-538-91Obagi Nu-Derm FX System Normal - Oily Skin Transformation Complexion Brightening System1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-538OBAGI NU-DERM FX SYSTEM NORMAL - OILY SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM (HOMOSALATE, OCTISALATE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20250406_04cec275-161a-41d2-b171-33d11f15d324.zip

Products#

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

DailyMed product names page 1 of 3 · 97 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-53862032-538-91

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 134 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
PHENOXYETHANOLHIE492ZZ3TINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
BUTYLPARABEN3QPI1U3FV8INGR
ETHYLPARABEN14255EXE39INGR
ISOBUTYLPARABEN0QQJ25X58GINGR
FD&C YELLOW NO. 5I753WB2F1MINGR
SODIUM LAUROYL OAT AMINO ACIDSFSW2K9B9N5INGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
ALOE VERA LEAFZY81Z83H0XINGR
SODIUM CHLORIDE451W47IQ8XINGR
MEDICAGO SATIVA WHOLEDJO934BRBDINGR
CHAMOMILEFGL3685T2XINGR
XANTHAN GUMTTV12P4NEEINGR
D&C RED NO. 339DBA0SBB0LINGR
REDCOLR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VINGR
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2INGR
DMDM HYDANTOINBYR0546TOWINGR
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBINGR
POTASSIUM ALUM1L24V9R23SINGR
PANTHENOLWV9CM0O67ZINGR
SAGE065C5D077JINGR
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDINGR
POLYSORBATE 806OZP39ZG8HINGR
ALLANTOIN344S277G0ZINGR
ALOE VERA LEAFZY81Z83H0XINGR
FD&C BLUE NO. 1H3R47K3TBDINGR
BLUECOLR
WATER059QF0KO0RINGR
ARBUTINC5INA23HXFINGR
CETYL ALCOHOL936JST6JCNINGR
GLYCERINPDC6A3C0OXINGR
SODIUM LAURYL SULFATE368GB5141JINGR
STEARYL ALCOHOL2KR89I4H1YINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR

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
Obagi Nu-Derm FX System Normal - Oily Skin Transformation Complexion Brightening SystemHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC04cec275-161a-41d2-b171-33d11f15d3242025-04-02WarningsExact identifier
ndc (package): 62032-538-91
ndc (product): 62032-538
ndc11 (package): 62032053891
spl id: 4fe691d6-0f60-499a-96b5-33f7eb291da1
spl set id: 04cec275-161a-41d2-b171-33d11f15d324

Reported adverse events (FAERS/openFDA)#

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