Emme Diane Tinted Mineral Sunscreen

Product NDC
81377-203
11-digit product format
813770203
Labeler code
81377
Product ID
81377-203_4fa7325c-8433-40a6-80d9-e0eb6afe79f0
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Emme Diane, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-22
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct81377-203UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81377-20381377-203-50UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Emme Diane Tinted Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

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
ab53ad98-b667-4447-8177-724dbf771e80Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81377-203-50Emme Diane Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81377-203EMME DIANE TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMME DIANE, INC]2Current NDC, Legacy NDC, 1 package rows20250119_ab53ad98-b667-4447-8177-724dbf771e80.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 199 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lipid Shield SPF 30ZINC OXIDEAllure Labs3bce820a-147b-5d8b-e063-6294a90a570d2025-08-07WarningsExact identifier
application number: M020
GR LONGSTAY Matte Face Powder SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI62759398-4935-4732-b950-cfbeab82bc5a2025-08-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3bac8d0a-8726-46c3-e063-6294a90a10752025-08-06WarningsExact identifier
application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC33478e28-b079-4e52-9924-845d127be2862025-08-06WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC805048c4-f2b3-4d35-8674-f44cf3d1a4b52025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBARdeddb91d-b2d5-4d97-bc38-5c11abde9d432025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBAR7f16b91d-29e4-4c21-a008-5dcc858c83d82025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9efa5db5-d774-4089-895c-9667eda0f11b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L76232666-e23f-4842-bd0d-37819739ec3a2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L876b9a5d-dae3-47f1-9da6-b5e179fd28cd2025-08-06WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3bba29ab-0e08-b751-e063-6294a90adb7b2025-08-06WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSTITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC3bba70e9-da29-f43b-e063-6294a90a08ef2025-08-06WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe36550a6-a231-41a8-abda-afdbb2449eaa2025-08-06WarningsExact identifier
application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream PaletteOCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIcca417c8-b882-48a7-8bd8-ccc6f961a3d22025-08-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81377-203-508137702035053 g in 1 BOTTLE, PUMP (81377-203-50) 53 g2022-09-150000-00-00NoNoCurrent