Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark

Product NDC
71398-014
11-digit product format
713980014
Labeler code
71398
Product ID
71398-014_a8d02db9-311d-408e-8283-14e903f5d0bd
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
SENT�, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-10
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
47.43; 87.048 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct71398-014IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71398-01471398-014-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE47.43 mg/mL
ZINC OXIDE87.048 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aedde765-931f-430e-9fc3-d87bde2b78cdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71398-014EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 36 MEDIUM - DARK (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SENTÉ, INC.]2Current NDC, Legacy NDC, 2 package rows20240415_aedde765-931f-430e-9fc3-d87bde2b78cd.zip

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 80 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oiana Mineral Sunscreen DropsZINC OXIDEOiana LLC4860257d-a8bf-7ce5-e063-6394a90a74db2026-01-14WarningsExact identifier
application number: M020
Standard Procedure Lip Balm SPF 50ZINC OXIDE HOMOSALATE OCTOCRYLENEStandard Procedure Inc1e3db995-b1c5-3a2e-e063-6294a90af75e2026-01-14WarningsExact identifier
application number: M020
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.48654406-505b-518b-e063-6394a90a5add2026-01-14WarningsExact identifier
application number: M020
JAYSUING Hyaluronic Acid Moisturizing SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.48662fae-2d41-4a4a-e063-6394a90a15222026-01-14WarningsExact identifier
application number: M020
CALIFORNIA ALOE FRESH POW DERY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENATURE REPUBLIC CO., LTD.aa10dbbf-97b3-4258-bbd3-0d8cc9935e122026-01-13WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4840f608-944a-3e3d-e063-6394a90a1d9d2026-01-13WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCb043f0f3-b263-4c49-86ca-9ecc71a22aa82026-01-13WarningsExact identifier
application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project SoothingHOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a60051-d57c-a341-e063-6394a90a92432026-01-13WarningsExact identifier
application number: M020
Sun GuardZINC OXIDESaje Natural Business Inc87ee593d-668c-f592-e053-2a95a90a17b12026-01-13WarningsExact identifier
application number: M020
Vixin Beach Face Sunscreen SPF50ZINC OXIDEVeganic SKN Limited482ae347-d175-52f2-e063-6394a90a92b02026-01-12WarningsExact identifier
application number: M020
FRE Glow ME Lightweight Tinted MoisturizerZINC OXIDEPeer Pharm Ltd1cf5b24a-e6fd-470a-e063-6294a90ab29c2026-01-12WarningsExact identifier
application number: M020
Botao Baby Mineral Sunscreen LZINC OXIDEPeer Pharm Ltd.e1564df9-90cb-0b1f-e053-2a95a90acb5e2026-01-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71398-014-01713980014011 TUBE in 1 CARTON (71398-014-01) / 50 mL in 1 TUBE1 tube2022-06-100000-00-00NoNoCurrent