FDA.reportPublic FDA data

Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark

Manufacturer
SENTÉ, Inc.
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:23

Label at a glance#

ProductEven Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
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: After 40 minutes of swimming or sweating Immediately after towel drying 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...

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 4.25%Sunscreen
Zinc Oxide 7.80%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:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Dimethicone, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sodium Chloride, Heparan Sulfate, Glycerin, Fructose, Tocopheryl Acetate, Tocopherol, Withania Somnifera Root Extract, Iron Oxides (C.I. 77491, C.I. 77492, C.I. 77499), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Polyglyceryin-3 Crosspolymer, Stearic Acid, Alumina, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin.

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senté®

Even Tone
Mineral Sunscreen

Broad Sprectrum Lotion
SPF 36

MEDIUM - DARK
Water Resistant (40 minutes)

HSA

PROTECT

50 mL / 1.7 FL OZ

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71398-014-012026-01-29C16284748780-11030e365-0e3f-111a-e063-dadaa90a10e2Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
71398-014-012024-04-12C16284748780-11030e365-0e3f-111a-e063-dadaa90a10e2Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
71398-014-012024-01-30C16284748780-11030e365-0e3f-111a-e063-dadaa90a10e2Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71398-014-01Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark50 mL in 1 TUBELOTION503
71398-014-01Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark1 in 1 CARTONLOTION13

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71398-01471398-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Dimethicone92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
Pentylene Glycol50C1307PZGIACT
Hexyl Laurate4CG9F9W01QIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
Polyglyceryl-4 Isostearate820DPX33S7IACT
Sodium Chloride451W47IQ8XIACT
HEPARAN SULFATE (PORCINE 5500 MW)47959853R5IACT
GlycerinPDC6A3C0OXIACT
Fructose6YSS42VSEVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TocopherolR0ZB2556P8IACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone25G622K2RAIACT
Stearic Acid4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PEG/PPG-18/18 Dimethicone9H0AO7T794IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PhenoxyethanolHIE492ZZ3TIACT
Ethylhexylglycerin147D247K3PIACT

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
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
ndc (package): 71398-014-01
ndc (product): 71398-014
ndc11 (package): 71398001401
spl id: a8d02db9-311d-408e-8283-14e903f5d0bd
spl set id: aedde765-931f-430e-9fc3-d87bde2b78cd

Reported adverse events (FAERS/openFDA)#

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