FDA.reportPublic FDA data

Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen

Manufacturer
SENTÉ, Inc.
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:51

Label at a glance#

ProductInvisible Shield Full Physical Tinted SPF 52 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 5.75%Sunscreen
Zinc Oxide 11.15%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 10 a.m.-2 p.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), Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Caprylyl Methicone, Acetamidoethoxyethanol, Steareth-2, Polyhydroxystearic Acid, Steareth-21, Glycerin, Biosaccharide Gum-4, Fructose, Withania Somnifera Root Extract, Yeast Extract, Hydrolyzed Candida Saitoana Extract, Cichorium Intybus (Chicory) Root Extract, Batyl Alcohol, Stearic Acid, Alumina, Triethoxycaprylylsilane, Xanthan Gum, Phytic Acid, Sodium Hydroxide, Propanediol, Caprylyl Glycol, Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA, Iron Oxides (CI 77491, CI 77492, CI 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®

Invisible Shield
Full Physical

TINTED

Broad Spectrum SPF 52
Sunscreen Lotion
PA ++++

PROTECT

1.8 OZ/52 g

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
71398-012-012024-04-08C16284748780-1f386c64a-35af-0266-e053-dadaa90a7c1aInvisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen
71398-012-012023-01-30C16284748780-1f386c64a-35af-0266-e053-dadaa90a7c1aInvisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71398-012-01Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen52 g in 1 TUBELOTION523
71398-012-01Invisible Shield Full Physical Tinted SPF 52 Broad Spectrum Sunscreen1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71398-012INVISIBLE SHIELD FULL PHYSICAL TINTED SPF 52 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.]3Legacy NDC, 2 package rows20240410_7553d6c9-1d23-4326-bb08-b0aaf2b42a7a.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71398-01271398-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Caprylyl TrisiloxaneQ95M2P1KJLIACT
Steareth-2V56DFE46J5IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Steareth-2153J3F32P58IACT
GlycerinPDC6A3C0OXIACT
Biosaccharide Gum-49XRL057X90IACT
Fructose6YSS42VSEVIACT
Withania Somnifera RootV038D626IFIACT
Yeast, Unspecified3NY3SM6B8UIACT
CICHORIUM INTYBUS (CHICORY) ROOT OLIGOSACCHARIDES38AFY41EARIACT
Batilol39YR661C4UIACT
Stearic Acid4ELV7Z65APIACT
Aluminum OxideLMI26O6933IACT
TriethoxycaprylylsilaneLDC331P08EIACT
Xanthan GumTTV12P4NEEIACT
Fytic Acid7IGF0S7R8IIACT
Propanediol5965N8W85TIACT
Caprylyl Glycol00YIU5438UIACT
Caprylhydroxamic AcidUPY805K99WIACT
1,2-HexanediolTR046Y3K1GIACT
Edetate Disodium7FLD91C86KIACT
Ferrosoferric OxideXM0M87F357IACT
Ferric Oxide Red1K09F3G675IACT
Ferric Oxide YellowEX438O2MRTIACT
Sodium Hydroxide55X04QC32IIACT

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
76ae447d-05c3-4dd0-9c50-c3c68a4455bf7553d6c9-1d23-4326-bb08-b0aaf2b42a7a2024-04-04WarningsExact identifier
spl id: 76ae447d-05c3-4dd0-9c50-c3c68a4455bf
spl set id: 7553d6c9-1d23-4326-bb08-b0aaf2b42a7a

Reported adverse events (FAERS/openFDA)#

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