FDA.reportPublic FDA data

Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC. | Denison Pharmaceuticals, LLC | Swiss-American CDMO, LLC | TENCO ASSEMBLIES, INC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:39

Label at a glance#

ProductObagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)
Active ingredientHOMOSALATE, 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

BACK to BASICS

OBAGI®
MEDICAL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-693-012025-04-01C16284748780-12cef2736-99c7-d83d-e063-dadaa90ab31fObagi ® Medical Back to Basics (Including Obagi Medical Professional-C Serum 20%)
62032-693-012025-01-30C16284748780-12cef2736-99c7-d83d-e063-dadaa90ab31fObagi ® Medical Back to Basics (Including Obagi Medical Professional-C Serum 20%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-693-01Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)1 in 1 BAGKIT12
62032-693-01Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-693OBAGI MEDICAL BACK TO BASICS (INCLUDING OBAGI MEDICAL PROFESSIONAL-C SERUM 20) (HOMOSALATE, OCTISALATE, AND ZINC OXIDE) KIT [OBAGI COSMECEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20250406_e8d19915-8996-42df-a47b-2ce00d2bbe68.zip

Products#

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

DailyMed product names page 1 of 3 · 113 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-69362032-693-01

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 142 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418INGR
ACETYL HEXAMETHYL TETRALIN360Q8Z01IPINGR
MEDICAGO SATIVA WHOLEDJO934BRBDINGR
ALOE VERA LEAFZY81Z83H0XINGR
BORAGO OFFICINALIS SEED2GXJ790US0INGR
BUTYLPARABEN3QPI1U3FV8INGR
BUTYLPHENYL METHYLPROPIONALT7540GJV69INGR
CHAMOMILEFGL3685T2XINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
D&C RED NO. 339DBA0SBB0LINGR
DIHYDROMYRCENOL46L1B02ND9INGR
DIOSCOREA VILLOSA TUBERIWY3IWX2G8INGR
ETHYLPARABEN14255EXE39INGR
FD&C YELLOW NO. 5I753WB2F1MINGR
GERANYL ACETATE3W81YG7P9RINGR
GLYCERINPDC6A3C0OXINGR
HEXYL SALICYLATE8F78EY72YLINGR
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDEQUE43B9Z2QINGR
ISOBUTYLPARABEN0QQJ25X58GINGR
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BINGR
LIMONENE, (+)-GFD7C86Q1WINGR
LINALOOL, (+/-)-D81QY6I88EINGR
METHYLPARABENA2I8C7HI9TINGR
PHENOXYETHANOLHIE492ZZ3TINGR
PHENYLETHYL ALCOHOLML9LGA7468INGR
PROPYLPARABENZ8IX2SC1OHINGR
QUILLAJA SAPONARIA BARK8N0K3807ZWINGR
SMILAX ARISTOLOCHIIFOLIA ROOTNR100Y25G0INGR
SODIUM CHLORIDE451W47IQ8XINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
SODIUM LAUROYL OAT AMINO ACIDSFSW2K9B9N5INGR
WATER059QF0KO0RINGR
XANTHAN GUMTTV12P4NEEINGR
YUCCA SCHIDIGERA ROOTE2H9ET15ATINGR
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418INGR
ACETYL HEXAMETHYL TETRALIN360Q8Z01IPINGR
ALLANTOIN344S277G0ZINGR
ALOE VERA LEAFZY81Z83H0XINGR
BORAGO OFFICINALIS SEED2GXJ790US0INGR
BUTYLPHENYL METHYLPROPIONALT7540GJV69INGR

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
ndc (package): 62032-693-01
ndc (product): 62032-693
ndc11 (package): 62032069301
spl id: b3db73ac-99c7-4be6-b020-2f87cbf124af
spl set id: e8d19915-8996-42df-a47b-2ce00d2bbe68

Reported adverse events (FAERS/openFDA)#

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