SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN LOTION

Manufacturer
Obagi Cosmeceuticals LLC | Swiss-American CDMO, LLC
Effective date
2021-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:05

Label at a glance#

ProductSUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN
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 children under 6 months: Ask a doctor 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 includi...

Storage and handling

store at controlled room temperature: 15ºC–25ºC (59ºF–77ºF) 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
Titanium dioxide 6.2%Sunscreen
Zinc oxide 15.6%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 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
  • children under 6 months: Ask a doctor
  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature: 15ºC–25ºC (59ºF–77ºF)
  • 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 - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI™
MEDICAL

Sun Shield
MINERAL
Broad
Spectrum
SPF 50

Sunscreen
Lotion

PA++++
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
62032-811-092024-01-30C16284748780-11030e365-4cb1-111a-e063-dadaa90a10e2SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-811-09SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN85 g in 1 TUBELOTION851
62032-811-09SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-811SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OBAGI COSMECEUTICALS LLC]1Legacy NDC, 2 package rows20210212_c0d229c8-ff22-47ca-9aed-8e3bdebc3fb1.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62032-81162032-811-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi-C C-Rx system Normal-oily skin InterventionHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa9ceacb3-d6e4-4316-a4e9-f15e574cdda02025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi-C C-Rx System Normal-Dry Skin InterventionHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCe9d8488f-b902-45f4-a6d6-c6eb393c8f082025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm System Normal-Oily Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCef3ddd1e-9305-42bb-a5f8-559e8e641d832025-11-05WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Nu-Derm System Normal-Dry Skin TransformationHYDROQUINONE, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC750ea9a6-eedc-49db-8cef-1498ed41ad792025-11-04WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
ndc (package): 62032-811-09
ndc11 (package): 62032081109
5c7fbfd0-d6f8-43ff-a171-199e48a10339c0d229c8-ff22-47ca-9aed-8e3bdebc3fb12021-02-04WarningsExact identifier
spl id: 5c7fbfd0-d6f8-43ff-a171-199e48a10339
spl set id: c0d229c8-ff22-47ca-9aed-8e3bdebc3fb1

Reported adverse events (FAERS/openFDA)#

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