FDA.reportPublic FDA data

Obagi

Manufacturer
Obagi Cosmeceuticals LLC | Swiss-American CDMO, LLC
Effective date
2021-02-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:06

Label at a glance#

ProductObagi Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50
Active ingredientHOMOSALATE, OCTINOXATE, TITANIUM 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 value of 15 or higher and other sun protection measures including: ▪ limit time in the sun, e...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose

Homosalate 10%

Octinoxate 7.5%

Titanium dioxide 3.22%

Sunscreen

Sunscreen

Sunscreen

Zinc oxide 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
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • 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

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

Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Polyglyceryl-10 Pentastearate, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Behenyl Alcohol, Physalis Angulata Extract, Dimethicone, PEG-40 Stearate, Phenoxyethanol, Lithothamnion Calcareum Powder, Glycerin, Mica, Sodium Stearoyl Lactylate, Polyhydroxystearic Acid, Mannitol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric Acid, Squalane, Xanthan Gum, Alumina, Stearic Acid, Diatomaceous Earth, Sodium Polyacrylate, Disodium EDTA, Ethylhexylglycerin, Synthetic Fluorphlogopite, Polysorbate 60, Zinc Sulfate, Sorbitan Oleate, Chlorphenesin, Tetrahexyldecyl Ascorbate, Tocopherol, Tin Oxide, Iron Oxides

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 - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI™
MEDICAL

Sun Shield

Broad
Spectrum
SPF 50
Sunscreen
Lotion

WARM
TINT

Infrared
Defense

Non-comedogenic
Dermatologist tested

Net wt. 3 oz. (85 g)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-160-102025-01-30C16284748780-12cef2736-a5b9-d83d-e063-dadaa90ab31fOBAGI ® Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-160-10ObagiSun Shield TINT Warm Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION13
62032-160-10ObagiSun Shield TINT Warm Sunscreen Broad Spectrum SPF 5085 g in 1 TUBELOTION853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-160OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OBAGI COSMECEUTICALS LLC]3Legacy NDC, 2 package rows20210213_b1aacb4d-7ede-4aae-8d6a-afff2a057e46.zip

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-16062032-160-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
12-OXOOCTADECANOIC ACID31GL7GRO8FIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
DOCOSANOL9G1OE216XYIACT
FERRIC OXIDE RED1K09F3G675IACT
PEG-40 STEARATEECU18C66Q7IACT
DIMETHICONE92RU3N3Y1OIACT
PHYSALIS ANGULATA WHOLEW4TKW9D5GGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FUCUS VESICULOSUS535G2ABX9MIACT
GLYCERINPDC6A3C0OXIACT
MICAV8A1AW0880IACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MANNITOL3OWL53L36AIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SQUALANEGW89575KF9IACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 60CAL22UVI4MIACT
ZINC SULFATE, UNSPECIFIED FORM89DS0H96TBIACT
CHLORPHENESINI670DAL4SZIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
STANNIC OXIDEKM7N50LOS6IACT

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
aba674be-7709-4424-a7cb-180319280978b1aacb4d-7ede-4aae-8d6a-afff2a057e462021-02-11WarningsExact identifier
spl id: aba674be-7709-4424-a7cb-180319280978
spl set id: b1aacb4d-7ede-4aae-8d6a-afff2a057e46

Reported adverse events (FAERS/openFDA)#

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