FDA.reportPublic FDA data

Pollution Shield SPF 46 Broad Spectrum Sunscreen

Manufacturer
SENTÉ, Inc.
Effective date
2017-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:38

Label at a glance#

ProductPollution Shield SPF 46 Broad Spectrum Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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 Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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

Protect the product in this container 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 5.3%Sunscreen
Zinc Oxide 14.5%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 - 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
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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 10a.m.-2p.m.
    • Wear long- sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Glycerin, Steareth-2, Cetearyl Alcohol, Polymethylsilsesquioxane, Steareth-21, Silica, Polyhydroxystearic Acid, Hydrolyzed Candida Saitoana Extract, Glycine Max (Soybean) Seed Extract, Yeast Extract, Biosaccharide Gum-4, Dimethicone, Dipotassium Glycyrrhizate, Propanediol, Stearic Acid, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, 1,2-Hexanediol, Sodium C14-16 Olefin Sulfonate, Caprylhydroxamic Acid, Alumina, Caprylyl Glycol, Xanthan Gum, Disodium EDTA. Iron Oxides (Cl 77491, Cl 77492, Cl 77499).

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 52 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SENTÉ
Glycosaminoglycans

Pollution Shield

Broad Spectrum
SPF 46 Sunscreen

Full Physical
Tinted

PA++++

BOOST
SHIELD

NET WT. 1.8 OZ/52g

PRINCIPAL DISPLAY PANEL - 52 g Tube Carton
PRINCIPAL DISPLAY PANEL - 52 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71398-001-012020-01-31C16284748780-19d75b9d0-d9cf-f424-e053-dadaa90a57cePollution Shield SPF 46 Broad Spectrum Sunscreen
71398-001-022020-01-31C16284748780-19d75b9d0-d9cf-f424-e053-dadaa90a57cePollution Shield SPF 46 Broad Spectrum Sunscreen
71398-001-042020-01-31C16284748780-19d75b9d0-d9cf-f424-e053-dadaa90a57cePollution Shield SPF 46 Broad Spectrum Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71398-001-01Pollution Shield SPF 46 Broad Spectrum Sunscreen1 in 1 CARTONLOTION11
71398-001-01Pollution Shield SPF 46 Broad Spectrum Sunscreen52 g in 1 TUBELOTION521
71398-001-02Pollution Shield SPF 46 Broad Spectrum Sunscreen1 in 1 CARTONLOTION11
71398-001-02Pollution Shield SPF 46 Broad Spectrum Sunscreen11.3 g in 1 TUBELOTION11.31
71398-001-04Pollution Shield SPF 46 Broad Spectrum Sunscreen2 g in 1 PACKETLOTION21
71398-001-04Pollution Shield SPF 46 Broad Spectrum Sunscreen1 in 1 BLISTER PACKLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71398-001POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.]1Legacy NDC, 6 package rows20170615_df69d75a-4a7f-4fb3-8c84-6d06e97e2b0e.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71398-00171398-001-01, 71398-001-04, 71398-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Dicaprylyl Carbonate609A3V1SUAIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
GlycerinPDC6A3C0OXIACT
Steareth-2V56DFE46J5IACT
Cetostearyl Alcohol2DMT128M1SIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
Steareth-2153J3F32P58IACT
Silicon DioxideETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SoybeanL7HT8F1ZODIACT
Yeast, Unspecified3NY3SM6B8UIACT
Biosaccharide Gum-49XRL057X90IACT
Dimethicone92RU3N3Y1OIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT
Propanediol5965N8W85TIACT
Stearic Acid4ELV7Z65APIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Sodium Stearoyl Glutamate65A9F4P024IACT
1,2-HexanediolTR046Y3K1GIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
Caprylhydroxamic AcidUPY805K99WIACT
Aluminum OxideLMI26O6933IACT
Caprylyl Glycol00YIU5438UIACT
Xanthan GumTTV12P4NEEIACT
Edetate Disodium7FLD91C86KIACT
Ferrosoferric OxideXM0M87F357IACT
Ferric Oxide Red1K09F3G675IACT
Ferric Oxide YellowEX438O2MRTIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ddd7e3c9-9948-48a8-a4d3-f45004e308cbdf69d75a-4a7f-4fb3-8c84-6d06e97e2b0e2017-05-12WarningsExact identifier
spl id: ddd7e3c9-9948-48a8-a4d3-f45004e308cb
spl set id: df69d75a-4a7f-4fb3-8c84-6d06e97e2b0e

Reported adverse events (FAERS/openFDA)#

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