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
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation
- Manufacturer
- Obagi Cosmeceuticals LLC | Bay Cities Container Corporation | Swiss American CDMO, LLC | G. S. Cosmeceutical USA, Inc.
- Effective date
- 2025-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:40:08
Label at a glance#
ProductObagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure10 sections
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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients | Purpose |
|---|---|
| Homosalate 10% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Zinc Oxide 16.5% | Sunscreen |
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
Warnings
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
- 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
- store at controlled room temperature: 15°C–25°C (59°F–77°F)
- protect this product from excessive heat and direct sun
Inactive ingredients
Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone
Questions or comments?
1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST
SPL UNCLASSIFIED SECTION
Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806
PRINCIPAL DISPLAY PANEL - Kit Carton
OBAGI®
MEDICAL
OBAGI NU-DERM FX™ SYSTEM
Complete skin care system specially formulated for normal
to oily skin that includes arbutin-based skin brighteners.
NORMAL OILY
Skin Transformation Kit | Complexion Brightening System
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62032-140-09 | Obagi Nu-Derm Fx System Normal-Oily Skin TransformationComplexion Brightening System | 85 g in 1 TUBE | LOTION | 85 g | 165 mg in 1g | 4 |
| 62032-140-09 | Obagi Nu-Derm Fx System Normal-Oily Skin TransformationComplexion Brightening System | 1 in 1 CARTON | LOTION | 50 mg in 1g | 4 | |
| 62032-904-30 | Obagi Nu-Derm Fx System Normal-Oily Skin TransformationComplexion Brightening System | 1 in 1 CARTON | KIT | 1 | 4 |
Products#
Every source-derived product name is available through these pages.
- Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System
- Homosalate, Octisalate, Zinc Oxide
- NU-DERM FOAMING
- Cosmetic
- WATER
- PHENOXYETHANOL
- METHYLPARABEN
- PROPYLPARABEN
- BUTYLPARABEN
- ETHYLPARABEN
- ISOBUTYLPARABEN
- FD&C YELLOW NO. 5
- SODIUM LAUROYL OAT AMINO ACIDS
- COCAMIDOPROPYL BETAINE
- SODIUM LAURETH-3 SULFATE
- ALOE VERA LEAF
- SODIUM CHLORIDE
- MEDICAGO SATIVA WHOLE
- CHAMOMILE
- XANTHAN GUM
- D&C RED NO. 33
- NU-DERM TONER
- GLYCERIN
- HAMAMELIS VIRGINIANA TOP WATER
- SODIUM PYRROLIDONE CARBOXYLATE
- DMDM HYDANTOIN
- IODOPROPYNYL BUTYLCARBAMATE
- POTASSIUM ALUM
- PANTHENOL
- SAGE
- CALENDULA OFFICINALIS FLOWER
- POLYSORBATE 80
- ALLANTOIN
- FD&C BLUE NO. 1
- NU-DERM CLEAR FX SKIN BRIGHTENING
- ARBUTIN
- CETYL ALCOHOL
- SODIUM LAURYL SULFATE
- STEARYL ALCOHOL
- .ALPHA.-TOCOPHEROL ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62032-904 | 62032-904-30 |
| 62032-140 | 62032-140-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.