FDA.reportPublic FDA data

Obagi Nu-Derm FX System Normal - Dry

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 00:58:34

Label at a glance#

ProductObagi Nu-Derm FX System Normal - Dry 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 DRY

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-539-072025-04-03C16284748780-12cef2736-59b2-d83d-e063-dadaa90ab31fObagi ® Nu-Derm FX™ System Normal - Dry Skin Transformation Kit Complexion Brightening System
62032-539-072025-01-30C16284748780-12cef2736-59b2-d83d-e063-dadaa90ab31fObagi ® Nu-Derm FX™ System Normal - Dry Skin Transformation Kit Complexion Brightening System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-539-07Obagi Nu-Derm FX System Normal - Dry Skin Transformation Complexion Brightening System1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-539OBAGI NU-DERM FX SYSTEM NORMAL - DRY SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM (HOMOSALATE, OCTISALATE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20250406_512b20f0-60c8-47d4-a732-22fc999980d3.zip

Products#

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

DailyMed product names page 1 of 3 · 107 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-53962032-539-07

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 152 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
PHENOXYETHANOLHIE492ZZ3TINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
BUTYLPARABEN3QPI1U3FV8INGR
ETHYLPARABEN14255EXE39INGR
ISOBUTYLPARABEN0QQJ25X58GINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM LAUROYL OAT AMINO ACIDSFSW2K9B9N5INGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
ALOE VERA LEAFZY81Z83H0XINGR
GLYCERETH-73D2Y91QZ2HINGR
PANTHENOLWV9CM0O67ZINGR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BINGR
TROLAMINE9O3K93S3TKINGR
SAGE065C5D077JINGR
FD&C YELLOW NO. 5I753WB2F1MINGR
APRICOT KERNEL OIL54JB35T06AINGR
OLEYL LACTATEB3AWW0N3GMINGR
BORAGO OFFICINALIS SEED2GXJ790US0INGR
YellowCOLR
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
BORAGO OFFICINALIS SEED2GXJ790US0INGR
BLUECOLR
WATER059QF0KO0RINGR

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 - Dry Skin Transformation Complexion Brightening SystemHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC512b20f0-60c8-47d4-a732-22fc999980d32025-04-02WarningsExact identifier
ndc (package): 62032-539-07
ndc (product): 62032-539
ndc11 (package): 62032053907
spl id: 0ad34be9-6f0d-446b-8131-94f8e5f453b9
spl set id: 512b20f0-60c8-47d4-a732-22fc999980d3

Reported adverse events (FAERS/openFDA)#

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