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 156 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact identifier
application number: M020
EELHOE Matte Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.42cfa690-15fe-e5de-e063-6394a90a8e712025-11-27WarningsExact identifier
application number: M020
JAYSUING Moisturiser Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.42c307d9-aaa9-30df-e063-6294a90aa1142025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4494bea6-ab1f-aae6-e063-6394a90a184d2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44853202-6873-0bc8-e063-6394a90a05f02025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE43f43c5a-2680-f549-e063-6394a90aade32025-11-27WarningsExact identifier
application number: M020
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44954d7c-2a78-3df4-e063-6294a90ab56f2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and CocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE449712ab-5c23-7d50-e063-6394a90ab7fe2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44991f67-9160-ccce-e063-6394a90ada1f2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4499bcda-f0ba-878e-e063-6394a90a5fc02025-11-27WarningsExact identifier
application number: M020
EcoZinc Kids Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44615ae4-8206-122d-e063-6294a90a0b2c2025-11-27WarningsExact identifier
application number: M020
HANCHOBIT SunscreenTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.42fd5d3e-4e98-86d7-e063-6294a90a45c22025-11-27WarningsExact identifier
application number: M020
HANCHOBIT SunscreenTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.375b60f1-ad33-578a-e063-6294a90a1fc62025-11-27WarningsExact identifier
application number: M020
EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for WeldingZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386e35de-cd13-f430-e063-6394a90acc842025-11-27WarningsExact identifier
application number: M020
HANCHOBIT Matte Sun StickTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.375bacf7-9372-bff7-e063-6294a90ae67c2025-11-27WarningsExact 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