FDA.reportPublic FDA data

Obagi

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC | Swiss-American CDMO, LLC | TENCO ASSEMBLIES, INC
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:55:23

Label at a glance#

ProductObagi Skintrinsiq Antioxidant Protocol
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure11 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

Obagi® Professional-C™ Suncare SPF 30

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 8%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 2.79%Sunscreen
Oxybenzone 3%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. If product gets into eyes, rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a 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
  • 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

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-9

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™

ANTIOXIDANT 10%
PROTOCOL KIT

INCLUDES:

  • 60 Tips
  • Obagi Nu-Derm® Gentle Cleanser, 2 FL. OZ.
  • Obagi Nu-Derm® Toner, 2 FL. OZ.
  • Obagi Professional-C® Serum 10%, 1 FL. OZ.
  • Obagi Professional-C® Peptide Complex, 1 FL. OZ.
  • Obagi Professional-C® Suncare SPF 30, 1.7 OZ.

OBAGI®

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

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

Professional-C™
SUNCARE

BROAD SPECTRUM
SPF 30

SUNSCREEN

Net wt. 1.7 oz. (48 g)

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-906-062025-04-01C16284748780-1f386c649-bc58-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq Brightening Protocol Kit 10%
62032-906-062025-01-30C16284748780-1f386c649-bc58-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq Brightening Protocol Kit 10%
62032-906-062023-03-28C16284748780-1f386c649-bc58-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq Brightening Protocol Kit 10%
62032-906-062023-01-30C16284748780-1f386c649-bc58-0266-e053-dadaa90a7c1aObagi ® Skintrinsiq Brightening Protocol Kit 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-050-54Obagi Skintrinsiq Antioxidant Protocol48 g in 1 TUBECREAM48 g27.9 mg in 1g4
62032-050-54Obagi Skintrinsiq Antioxidant Protocol1 in 1 CARTONCREAM50 mg in 1g4
62032-906-06Obagi Skintrinsiq Antioxidant Protocol1 in 1 BOXKIT14

Products#

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

DailyMed product names page 1 of 2 · 76 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-90662032-906-06
62032-05062032-050-54

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 80 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
ASCORBIC ACIDPQ6CK8PD0RINGR
PROPYLENE CARBONATE8D08K3S51EINGR
PROPYLENE GLYCOL6DC9Q167V3INGR
WATER059QF0KO0RINGR

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC53023b16-8d64-4dfc-bc75-b4f248425c4d2026-04-27WarningsExact identifier
ndc (package): 62032-050-54
ndc (package): 62032-906-06
ndc (product): 62032-906
ndc11 (package): 62032005054
ndc11 (package): 62032090606
spl id: 449a23d3-1fdc-4573-bc1e-90bde2db93d3
spl set id: 53023b16-8d64-4dfc-bc75-b4f248425c4d
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
ndc (package): 62032-050-54
ndc11 (package): 62032005054

Reported adverse events (FAERS/openFDA)#

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