FDA.reportPublic FDA data

Titanium Dioxide and Zinc Oxide

Manufacturer
Obagi Cosmeceuticals LLC | G.S.COSMECEUTICAL USA, INC.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:14

Label at a glance#

ProductObagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD
Active ingredientTITANIUM DIOXIDE, 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10...

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 Ingredients
Titanium Dioxide 5.8%Sunscreen
Zinc Oxide 14.4%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 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
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Cetearyl Alcohol, Dimethicone, Propanediol, Polyhydroxystearic Acid, Cetearyl Glucoside, Aloe Barbadensis Leaf Extract, Brassica Oleracea Italica (Broccoli) Extract, Bioflavonoids, Dipotassium Glycyrrhizate, Polyglyceryl- 2, Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Sodium C14-16 Olefin Sulfonate Stearic Acid, Lauryl Glucoside, Triethoxycaprylylsilane, Xanthan Gum, Silica, Alumina, Caprylhydroxamic Acid, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)

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 - 96.3 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

PHYSICAL DEFENSE
50 Broad Spectrum Mineral Sunscreen
SPF 50 • PA++++
Lightly Tinted, Lightweight, and Sheer

BY SUZANOBAGIMD™

HEV • VIS • IR Protection

Net wt. 3.4 oz. (96.3 g)

PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton
PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-608-352025-03-14C16284748780-12cef2736-5db8-d83d-e063-dadaa90ab31fObagi ® Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD
62032-608-352025-01-30C16284748780-12cef2736-5db8-d83d-e063-dadaa90ab31fObagi ® Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-608-35Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD1 in 1 CARTONCREAM13
62032-608-35Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD96.3 g in 1 TUBECREAM96.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-608OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 50 BY SUZANOBAGIMD (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OBAGI COSMECEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20250316_ff95a7b7-3cb4-41b0-866d-69361354a0bc.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-60862032-608-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
PROPANEDIOL5965N8W85TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ALOE VERA LEAFZY81Z83H0XIACT
BROCCOLIUOI4FT57BZIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM OXIDELMI26O6933IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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 Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMDTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLCff95a7b7-3cb4-41b0-866d-69361354a0bc2025-01-01WarningsExact identifier
ndc (package): 62032-608-35
ndc (product): 62032-608
ndc11 (package): 62032060835
spl id: a31511b7-aa0f-420d-9f06-927b031e4f4f
spl set id: ff95a7b7-3cb4-41b0-866d-69361354a0bc

Reported adverse events (FAERS/openFDA)#

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