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 41 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light MediumZINC OXIDEZO Skin Health, Inc.4fabe9d0-27fe-230f-e063-6294a90a9ac02026-04-17WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-TanZINC OXIDEZO Skin Health, Inc.4fac82b7-d685-2a0d-e063-6394a90aa7952026-04-17WarningsExact identifier
application number: M020
SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4fae649d-f60e-0275-e063-6294a90a1ea52026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHTYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cfaea-b71f-2956-e063-6294a90a4f202026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUMYOUR NAME MINERAL SHEER TINTPML NYC, LLC316d1515-6092-a7d6-e063-6394a90ab8b22026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e70-6ec3-5711-e063-6394a90a38792026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC0e241343-db63-3f1c-e063-6394a90ab5382026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC316df5fe-0574-d59f-e063-6294a90af8b92026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316c5d69-46f4-7677-e063-6294a90a610f2026-04-17WarningsExact identifier
application number: M020
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20PML NYC, LLC316d905f-232c-d8a2-e063-6394a90adbc92026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NPML NYC, LLC316ea01b-4bff-55be-e063-6394a90add942026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NPML NYC, LLC316e97bc-4b96-ba6e-e063-6294a90a76482026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c781d7-9d48-892f-e053-2a95a90aca862026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c757b4-6c92-18f0-e053-2a95a90a246d2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c76a82-dc87-35e7-e053-2995a90ae3102026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7ac71-3f38-52b2-e053-2a95a90ab54e2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7b929-7492-f072-e053-2995a90a1ca32026-04-17WarningsExact 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