FDA.reportPublic FDA data

Obagi Skintrinsiq Clarifiying Protocol

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC | Swiss-American CDMO, LLC | TENCO ASSEMBLIES, INC
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:29

Label at a glance#

ProductObagi Skintrinsiq Clarifiying Protocol
Active ingredientSALICYLIC ACID, TITANIUM DIOXIDE, ZINC OXIDE
Label structure22 sections

Indications and uses

or the treatment of acne dries up acne pimples helps prevent new acne pimples

Dosage and administration

Cleanse the skin thoroughly before applying this product. Shake product well before use. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or ever...

Storage and handling

store away from heat and direct sunlight store at controlled room temperature: 15°–25°C (59°–77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Obagi® Medical CLENZIderm M.D.® Pore Therapy

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • or the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

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

  • Cleanse the skin thoroughly before applying this product.
  • Shake product well before use.
  • Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

STORAGE AND HANDLING SECTION

  • store away from heat and direct sunlight
  • store at controlled room temperature: 15°–25°C (59°–77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

SPL UNCLASSIFIED SECTION

Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen

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 - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

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
  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), 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

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

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

SKINTRINSIQ™

CLARIFYING
PROTOCOL KIT

INCLUDES:

  • 60 Tips
  • Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
  • Obagi Nu-Derm® Toner, 2 FL. OZ.
  • CLENZIderm M.D.® Pore Therapy, 5 FL. OZ.
  • Obagi Hydrate® Facial Moisturizer, 1.7 OZ.
  • Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ.

OBAGI®

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

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

CLENZIderm M.D.®

Pore Therapy

Salicylic Acid 2%
Acne Treatment

5 FL. OZ. (148 mL)

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI™
MEDICAL

Sun Shield
Broad
Spectrum
SPF 50

MINERAL

Sunscreen
Lotion

PA++++
Non-comedogenic
Dermatologist Tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235208CLENZIderm M.D. 2 % Pore Therapy Topical SolutionPSN3
251577salicylic acid 2 % Topical SolutionPSN3
1235208salicylic acid 20 MG/ML Topical Solution [Clenziderm]SBD3
251577salicylic acid 20 MG/ML Topical SolutionSCD3
1235208Clenziderm 20 MG/ML Topical SolutionSY3
1235208Clenziderm M.D. 2 % Pore TherapySY3
251577salicylic acid 2 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-909-092025-04-01C16284748780-1f386c649-c498-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq™ Clarifiying Protocol Kit
62032-909-092025-01-30C16284748780-1f386c649-c498-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq™ Clarifiying Protocol Kit
62032-909-092023-03-29C16284748780-1f386c649-c498-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq™ Clarifiying Protocol Kit
62032-909-092023-01-30C16284748780-1f386c649-c498-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq™ Clarifiying Protocol Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-612-04Obagi Skintrinsiq Clarifiying Protocol148 mL in 1 BOTTLE, PLASTICLIQUID148 mL20 mg in 1mL3
62032-811-09Obagi Skintrinsiq Clarifiying Protocol1 in 1 CARTONLOTION15.6 g in 100g3
62032-811-09Obagi Skintrinsiq Clarifiying Protocol85 g in 1 TUBELOTION85 g15.6 g in 100g3
62032-909-09Obagi Skintrinsiq Clarifiying Protocol1 in 1 BOXKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-612OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL (SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC20250406_08ba9ea8-73fd-472b-9cc4-67df167352ec.zip
62032-811OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL (SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Legacy NDC20250406_08ba9ea8-73fd-472b-9cc4-67df167352ec.zip
62032-909OBAGI SKINTRINSIQ CLARIFIYING PROTOCOL (SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 4 package rows20250406_08ba9ea8-73fd-472b-9cc4-67df167352ec.zip

Products#

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

DailyMed product names page 1 of 3 · 89 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-90962032-909-09
62032-61262032-612-04
62032-81162032-811-09

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 100 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XINGR
APRICOT KERNEL OIL54JB35T06AINGR
BORAGO OFFICINALIS SEED2GXJ790US0INGR
BUTYLPARABEN3QPI1U3FV8INGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BINGR
ETHYLPARABEN14255EXE39INGR
FD&C YELLOW NO. 5I753WB2F1MINGR
GLYCERETH-73D2Y91QZ2HINGR
GLYCERINPDC6A3C0OXINGR
ISOBUTYLPARABEN0QQJ25X58GINGR
METHYLPARABENA2I8C7HI9TINGR
OLEYL LACTATEB3AWW0N3GMINGR
PANTHENOLWV9CM0O67ZINGR
PHENOXYETHANOLHIE492ZZ3TINGR
PROPYLPARABENZ8IX2SC1OHINGR
SAGE065C5D077JINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
SODIUM LAUROYL OAT AMINO ACIDSFSW2K9B9N5INGR
TROLAMINE9O3K93S3TKINGR
WATER059QF0KO0RINGR
ALLANTOIN344S277G0ZINGR
ALOE VERA LEAFZY81Z83H0XINGR
BORAGO OFFICINALIS SEED2GXJ790US0INGR
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDINGR
DMDM HYDANTOINBYR0546TOWINGR
FD&C BLUE NO. 1H3R47K3TBDINGR
GLYCERINPDC6A3C0OXINGR
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VINGR
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBINGR
POLYSORBATE 806OZP39ZG8HINGR
POTASSIUM ALUM1L24V9R23SINGR
SAGE065C5D077JINGR
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2INGR
WATER059QF0KO0RINGR
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
CHAMOMILEFGL3685T2XIACT

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-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): 62032-811-09
ndc11 (package): 62032081109
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
ndc11 (package): 62032081109
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): 62032-909-09
ndc (package): 62032-612-04
ndc (package): 62032-811-09
ndc (product): 62032-909
ndc11 (package): 62032081109
ndc11 (package): 62032090909
ndc11 (package): 62032061204
spl id: a9c17c57-a3af-43d6-9db3-56fb8e28894b
spl set id: 08ba9ea8-73fd-472b-9cc4-67df167352ec
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
ndc (package): 62032-612-04
ndc11 (package): 62032061204
CLENZIDERM PORE THERAPY ACNE TREATMENTSALICYLIC ACIDObagi Cosmeceuticals LLC08c1a55e-a376-4cd6-896f-0ad2068a1fc02025-01-01WarningsExact identifier
ndc (package): 62032-612-04
ndc (product): 62032-612
ndc11 (package): 62032061204

Reported adverse events (FAERS/openFDA)#

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