FDA.reportPublic FDA data

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION

Manufacturer
Obagi Cosmeceuticals LLC | Swiss-American CDMO, LLC
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:15:33

Label at a glance#

ProductSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
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°–25°C (59°–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°–25°C (59°–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 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

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

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion

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
62032-140-052025-10-02C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION
62032-140-092025-10-02C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION
62032-140-342025-10-02C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION
62032-140-052025-01-30C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION
62032-140-092025-01-30C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION
62032-140-342025-01-30C16284748780-12cef2736-8318-d83d-e063-dadaa90ab31fSUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-140-05SUN SHIELD BROAD SPECTRUM SPF 50 MATTESUNSCREEN28 g in 1 TUBELOTION285
62032-140-09SUN SHIELD BROAD SPECTRUM SPF 50 MATTESUNSCREEN1 in 1 CARTONLOTION15
62032-140-09SUN SHIELD BROAD SPECTRUM SPF 50 MATTESUNSCREEN85 g in 1 TUBELOTION855
62032-140-34SUN SHIELD BROAD SPECTRUM SPF 50 MATTESUNSCREEN479 g in 1 BOTTLE, PUMPLOTION4795

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-14062032-140-34, 62032-140-09, 62032-140-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
C15-19 ALKANECI87N1IM01IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
SORBITAN OLIVATEMDL271E3GRIACT
DIMETHICONE92RU3N3Y1OIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
CANDELILLA WAXWL0328HX19IACT
YELLOW WAX2ZA36H0S2VIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi-C C-Rx System Normal-Dry Skin InterventionHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCca931d1c-4df4-47ce-8d5c-cd8c3e38c02b2026-01-26WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi-C Fx System Normal-Oily Skin Brightening System with ArbutinHOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC321e58d0-9964-4da9-af6b-66ba81b60cf72026-01-26WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemHOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC49cd9e72-4e25-4ff9-aefc-467733b105be2025-10-23WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Nu-Derm System Normal-Dry Skin Transformation KitHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC16efa2db-8172-4026-a519-08f53d68b3c92025-10-23WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Nu-Derm System Normal-Oily Skin TransformationHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCe63327db-fb96-411c-945a-abe801d380452025-10-23WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Nu-Derm System Normal-Oily Skin Transformation TrialHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLC219c68dc-1e74-4136-9065-85466008d4452025-10-23WarningsExact identifier
ndc (package): 62032-140-05
ndc11 (package): 62032014005
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Kit Complexion Brightening SystemHOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCcead2b1c-671d-45f9-b450-2827128792fe2025-10-23WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Nu-Derm System Normal-Dry Skin Transformation TrialHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCe2c23345-69df-47a1-8e6b-b6225080d3632025-10-23WarningsExact identifier
ndc (package): 62032-140-05
ndc11 (package): 62032014005
Obagi-C C-Rx System Normal-Oily Skin InterventionHYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDEObagi Cosmeceuticals LLCe19b824f-4438-48c8-af4c-29be197f9cdc2025-10-21WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Skintrinsiq Brightening ProtocolHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC2f75ebf7-d6b6-45c6-ad5b-61739d260ff72025-03-21WarningsExact identifier
ndc (package): 62032-140-09
ndc11 (package): 62032014009
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
ndc (package): 62032-140-05
ndc11 (package): 62032014005
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
ndc (package): 62032-140-34
ndc (package): 62032-140-09
ndc (package): 62032-140-05
ndc (product): 62032-140
ndc11 (package): 62032014009
ndc11 (package): 62032014005
ndc11 (package): 62032014034
spl id: 7415289e-2b1a-416a-ab5d-2fafa7059e17
spl set id: 263ef8e8-e0c4-42e6-bb26-7581a437b35a

Reported adverse events (FAERS/openFDA)#

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