Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Kit

Manufacturer
OMP, Inc. | Ei INC. | G.S. COSMECEUTICAL USA, INC. | Bay Cities Container Corporation
Effective date
2015-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:19

Label at a glance#

ProductObagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Kit
Active ingredientOCTINOXATE, ZINC OXIDE, HYDROQUINONE
Label structure38 sections

Indications and uses

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use twice daily, morning and evening. Massage a small amount of cleanser and water onto skin. Rinse with lukewarm water and gently pat dry.

Label contents#

Full prescribing information#

Gentle Cleanser AM+PM

SPL UNCLASSIFIED SECTION

A mild facial cleanser that provides gentle yet effective cleansing for normal to dry skin. For skin that’s beautifully clean and fresh, the Nu-Derm Gentle Cleanser instantly dissolves excess oil, makeup, and other everyday impurities, without stripping your skin of its natural protective oils, and prepares your skin for the next step in your skin care regimen.

Directions

SPL UNCLASSIFIED SECTION

Use twice daily, morning and evening. Massage a small amount of cleanser and water onto skin. Rinse with lukewarm water and gently pat dry.

Warnings

WARNINGS SECTION

Avoid getting into eyes. For external use only. Keep out of reach of children.

Ingredients

SPL UNCLASSIFIED SECTION

water (aqua), cocamidopropyl betaine, glycerin, sodium lauroyl oat amino acids, aloe barbadensis leaf juice, sodium laureth sulfate, glycereth-7, prunus armeniaca (apricot) kernel oil, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, oleyl lactate, ethoxydiglycol, triethanolamine, salvia officinalis (sage) leaf extract, borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)

Toner AM+PM

SPL UNCLASSIFIED SECTION

An essential step in your daily skin care routine, this alcohol-free, nondrying toner helps adjust your skin’s pH. Use after cleansing to remove impurities and dead skin cells and to prepare the skin for hydration or appropriate products.

Directions

SPL UNCLASSIFIED SECTION

Use daily, in the morning and evening after cleansing. Shake before use. Saturate a cotton pad and gently wipe over the entire face. Do not rinse.

Warnings

WARNINGS SECTION

Avoid getting into eyes. For external use only. Keep out of reach of children.

Ingredients

SPL UNCLASSIFIED SECTION

water (aqua), hamamelis virginiana (witch hazel) water, aloe barbadensis leaf juice, potassium alum, sodium PCA, panthenol, DMDM hydantoin, polysorbate 80, allantoin, glycerin, salvia officinalis (sage) leaf extract, borago officinalis extract, calendula officinalis flower extract, saponins, iodopropynyl butylcarbamate, fragrance (parfum), blue 1 (CI 42090)

Clear (Skin Bleaching and Corrector Cream) AM+PM

SPL UNCLASSIFIED SECTION

Dark spots may appear on the surface of your skin, but they actually start deep within the skin’s layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.

Indications and Usage

INDICATIONS & USAGE SECTION

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Use daily, in the morning and evening. Squeeze a small amount (approximately1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

WARNINGS SECTION

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Each gram of Obagi Nu-Derm Clear contains:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben

See enclosed Package Insert for prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Exfoderm® (Skin Smoothing Lotion) AM

SPL UNCLASSIFIED SECTION

A lightweight lotion that exfoliates the top layer of skin, removing dull, old skin cells while revealing new skin cells for a brighter complexion. Specifically developed for normal to dry skin, this gentle, skin-enhancing formula contains a plant acid (phytic acid) to help transform the appearance of damaged skin and reveal your skin’s radiance.

Directions

SPL UNCLASSIFIED SECTION

Use daily, in the morning. Squeeze a small amount (approximately 1 to 2 pea-size drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage until completely absorbed.

Warnings

WARNINGS SECTION

Avoid getting into eyes. For external use only. Keep out of reach of children.

Ingredients

SPL UNCLASSIFIED SECTION

water, ethoxydiglycol, glycerin, phytic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, magnesium aluminum silicate, canola oil, isohexadecane, potassium cetyl phosphate, cetyl alcohol, bis-diglyceryl polyacyladipate-2, dimethicone, sodium hydroxide, xanthan gum, phenoxyethanol, glycereth-7, polysorbate 60, methylparaben, PEG-150 stearate, steareth-20, tocopheryl acetate, saponins, ethylparaben, butylparaben, isobutylparaben, propylparaben

Hydrate (Facial Moisturizer) AM+PM

SPL UNCLASSIFIED SECTION

Obagi Hydrate® provides all-day moisture protection and is suitable for all skin types. Contains Hydromanil, a multi-action agent derived from tara seed, known to gradually deliver moisture to the skin. Also includes shea butter, mango butter, avocado, and glycerin to help combat skin dryness.

Directions

SPL UNCLASSIFIED SECTION

Apply to face in the morning and evening or as needed.

Warnings

WARNINGS SECTION

Avoid getting into eyes. For external use only. Keep out of reach of children.

Ingredients

SPL UNCLASSIFIED SECTION

water (aqua), glycerin, caprylic/capric triglyceride, butyrospermum parkii (shea) butter, cyclopentasiloxane, glyceryl stearate, cetyl alcohol, dimethicone, saccharide isomerate, stearic acid, polysilicone-11, glycine soja (soybean) sterols, persea gratissima (avocado) oil, mangifera indica (mango) seed butter, hydrolyzed caesalpinia spinosa gum, caesalpinia spinosa gum, hydrolyzed soybean fiber, sodium stearoyl glutamate, caprylyl glycol, bisabolol, allantoin, tocopherol, tetrahydrodiferuloylmethane, panthenol, carbomer, hexylene glycol, sodium hydroxide, laureth-12, ethylhexylglycerin, phenoxyethanol

Blender® (Skin Lightener and Blending Cream) PM

SPL UNCLASSIFIED SECTION

A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce signs of aging by correcting uneven skin tone.

Indications and Usage

INDICATIONS & USAGE SECTION

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

WARNINGS SECTION

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Each gram of Obagi Nu-Derm Blender contains:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

See enclosed Package Insert for prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY

Sun Shield Broad Spectrum SPF 50 Matte

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Zinc Oxide 10.5%

Purpose

OTC - PURPOSE SECTION

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

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is 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
  • children under 6 months: Ask a doctor
  • 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

Other information

SPL UNCLASSIFIED 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

1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time

Principal Display Panel - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®

MEDICAL

OBAGI NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Kit

Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Starter Kit
Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Starter Kit

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-526-062020-01-31C16284748780-19d75b9d0-7fc3-f424-e053-dadaa90a57ceOBAGI ® MEDICAL NU-DERM ® SYSTEM NORMAL to DRY Skin Transformation Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-526-06Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Kit1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-526OBAGI MEDICAL - NU-DERM SYSTEM - NORMAL TO DRY - SKIN TRANSFORMATION KIT (OCTINOXATE, ZINC OXIDE) KIT [OMP, INC.]1Legacy NDC, 1 package rows20151211_935a1c17-63d7-43ba-b02c-0736c0ca1277.zip

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-52662032-526-06

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
935a1c17-63d7-43ba-b02c-0736c0ca1277935a1c17-63d7-43ba-b02c-0736c0ca12772015-12-10WarningsExact identifier
spl id: 935a1c17-63d7-43ba-b02c-0736c0ca1277
spl set id: 935a1c17-63d7-43ba-b02c-0736c0ca1277

Reported adverse events (FAERS/openFDA)#

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