Obagi Nu-Derm System Normal-Dry Skin Transformation Trial

Manufacturer
Obagi Cosmeceuticals LLC | Swiss American CDMO, LLC | G. S. Cosmeceutical USA, Inc. | Bay Cities Container Corporation
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:41

Label at a glance#

ProductObagi Nu-Derm System Normal-Dry Skin Transformation Trial
Active ingredientHYDROQUINONE, HOMOSALATE, 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 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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

OBAGI NU-DERM ® SYSTEM
A total systematic approach to skin care. Addresses signs of skin
aging, gently exfoliates to promote cell turnover and suppresses
melanocyte activity to reduce hyperpigmentaion.

NORMAL DRY

Skin Transformation Trial 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 CreamPSN3
197795hydroquinone 40 MG/ML Topical CreamSCD3
197795hydroquinone 4 % Topical CreamSY3

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-Dry Skin Transformation Trial57 g in 1 BOTTLE, PLASTICCREAM28 g40 mg in 1g3
62032-101-36Obagi Nu-Derm System Normal-Dry Skin Transformation Trial57 g in 1 BOTTLE, PLASTICCREAM57 g40 mg in 1g3
62032-140-05Obagi Nu-Derm System Normal-Dry Skin Transformation Trial28 g in 1 TUBELOTION28 g50 mg in 1g3
62032-913-01Obagi Nu-Derm System Normal-Dry Skin Transformation Trial1 in 1 CARTONKIT13

Products#

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

DailyMed product names page 1 of 3 · 85 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 116 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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Nu-Derm System Normal-Oily Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCef3ddd1e-9305-42bb-a5f8-559e8e641d832025-11-05WarningsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032010036
Obagi Nu-Derm System Normal-Dry Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC750ea9a6-eedc-49db-8cef-1498ed41ad792025-11-04WarningsExact identifier
ndc (package): 62032-100-36
ndc (package): 62032-101-36
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): 62032-140-05
ndc (package): 62032-101-36
ndc11 (package): 62032010136
ndc11 (package): 62032014005
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): 62032-913-01
ndc (package): 62032-140-05
ndc (package): 62032-101-36
ndc (product): 62032-913
ndc11 (package): 62032091301
ndc11 (package): 62032010136
ndc11 (package): 62032014005
ndc11 (package): 62032010036
spl id: f1292c32-db82-4875-b681-b984c56f9cff
spl set id: e2c23345-69df-47a1-8e6b-b6225080d363
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
ndc (package): 62032-140-05
ndc11 (package): 62032014005
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
ndc (package): 62032-140-05
ndc (product): 62032-140
ndc11 (package): 62032014005
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.