Obagi Nu-Derm System Normal-Oily Skin Transformation

Manufacturer
Obagi Cosmeceuticals LLC | Bay Cities Container Corporation | Swiss American CDMO, LLC | G. S. Cosmeceutical USA, Inc. | PURETEK CORPORATION
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:43

Label at a glance#

ProductObagi Nu-Derm System Normal-Oily Skin Transformation
Active ingredientHYDROQUINONE, TITANIUM DIOXIDE, 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
Titanium Dioxide 6.2%Sunscreen
Zinc Oxide 15.6%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

aqua/water/eau, caprylic/capric triglyceride, dicaprylyl carbonate, pentylene glycol, steareth-2, glycerin, silica, polyhydroxystearic acid, steareth-21, cetearyl alcohol, propanediol, alumina, stearic acid, sodium stearoyl glutamate, caprylyl glycol, triethoxycaprylylsilane, cetearyl glucoslde, xanthan gum, dipotassium glycyrrhizate,trisodium ethylenediamine disuccinate, caprylhydroxamic acid, tropaeolum majus flower/leaf/stem extract.

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST

OTC - WHEN USING 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® SYSTEM

Addresses signs of skin aging, gently exfoliates to promote cell turnover and
suppresses melanocyte activity to reduce hyperpigmentaion.

NORMAL OILY

Skin Transformation Kit

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197795hydroquinone 4 % Topical CreamPSN1
197795hydroquinone 40 MG/ML Topical CreamSCD1
197795hydroquinone 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-100-36Obagi Nu-Derm System Normal-Oily Skin Transformation57 g in 1 BOTTLE, PLASTICCREAM57 g40 mg in 1g1
62032-101-36Obagi Nu-Derm System Normal-Oily Skin Transformation57 g in 1 BOTTLE, PLASTICCREAM57 g40 mg in 1g1
62032-811-09Obagi Nu-Derm System Normal-Oily Skin Transformation85 g in 1 TUBELOTION85 g6.2 g in 100g1
62032-811-09Obagi Nu-Derm System Normal-Oily Skin Transformation1 in 1 CARTONLOTION6.2 g in 100g1
62032-919-01Obagi Nu-Derm System Normal-Oily Skin Transformation1 in 1 BAGKIT11

Products#

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

DailyMed product names page 1 of 3 · 96 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 129 matching rows.

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi-C C-Rx system Normal-oily skin InterventionHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa9ceacb3-d6e4-4316-a4e9-f15e574cdda02025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi-C C-Rx System Normal-Dry Skin InterventionHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCe9d8488f-b902-45f4-a6d6-c6eb393c8f082025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm System Normal-Oily Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCef3ddd1e-9305-42bb-a5f8-559e8e641d832025-11-05WarningsExact identifier
ndc (package): 62032-919-01
ndc (package): 62032-811-09
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc (product): 62032-919
ndc11 (package): 62032081109
ndc11 (package): 62032091901
ndc11 (package): 62032010136
ndc11 (package): 62032010036
spl id: 41157f8f-7840-42f7-85cd-f16fff7862cc
spl set id: ef3ddd1e-9305-42bb-a5f8-559e8e641d83
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm System Normal-Dry Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC750ea9a6-eedc-49db-8cef-1498ed41ad792025-11-04WarningsExact identifier
ndc (package): 62032-811-09
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032081109
ndc11 (package): 62032010136
ndc11 (package): 62032010036
Obagi Nu-Derm System Normal-Dry Skin Transformation KitHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC16efa2db-8172-4026-a519-08f53d68b3c92025-10-23WarningsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032010036
Obagi Nu-Derm System Normal-Oily Skin TransformationHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCe63327db-fb96-411c-945a-abe801d380452025-10-23WarningsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032010036
Obagi Nu-Derm System Normal-Oily Skin Transformation TrialHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC219c68dc-1e74-4136-9065-85466008d4452025-10-23WarningsExact identifier
ndc (package): 62032-101-36
ndc11 (package): 62032010136
Obagi Nu-Derm System Normal-Dry Skin Transformation TrialHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCe2c23345-69df-47a1-8e6b-b6225080d3632025-10-23WarningsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032010036
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
nu-derm system normal-dry skin transformationHYDROQUINONE, OCTISALATE AND ZINC OXIDEOBAGI COSMECEUTICAL LLC7548658a-5371-4aed-baf8-e5dc542622232025-03-14Warnings, Adverse reactionsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032010036
NU-DERM BLENDER Skin Lightener and BlendingHYDROQUINONEObagi Cosmeceuticals LLCe5c450af-958e-41e3-9c2f-fda76b3596f52025-01-01Warnings, Adverse reactionsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc (product): 62032-100
ndc (product): 62032-101
ndc11 (package): 62032010136
ndc11 (package): 62032010036

Reported adverse events (FAERS/openFDA)#

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