FDA.reportPublic FDA data

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50

Product NDC
64768-2924
11-digit product format
647682924
Labeler code
64768
Product ID
64768-2924_369e880d-d765-f24b-e063-6394a90af418
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Expanscience Laboratories d/b/a Mustela
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
ZINC OXIDE
Active strength
240 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64768-292464768-2924-2DDiscontinued by firm2026-10-23
excluded packagepackage64768-292464768-2924-3DDiscontinued by firm2026-10-23

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 · 20 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0564768-2924-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0564768-2924-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2664768-2924-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3164768-2924-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3164768-2924-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2864768-2924-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2864768-2924-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2164768-2924-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2164768-2924-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1064768-2924-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1064768-2924-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3164768-2924-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3164768-2924-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2064768-2924-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2064768-2924-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1064768-2924-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1064768-2924-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0864768-2924-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0364768-2924-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0964768-2924-2557ba5c1ecfa…9c80585c8c6e…

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
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE240 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
95ea5442-a7ca-0c7d-e053-2a95a90ad247Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2924-1MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50100 mL in 1 TUBELOTION1006
64768-2924-2MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50500 mL in 1 BOTTLE, PUMPLOTION5006
64768-2924-3MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50325 mL in 1 BOTTLE, PUMPLOTION3256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2924MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]5Current NDC, Legacy NDC, 3 package rows20241204_95ea5442-a7ca-0c7d-e053-2a95a90ad247.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 88 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
application number: M020
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
application number: M020
EVERYRAY SUNCARE SUNSHINE SERUMEVERYRAY SUNCARE SUNSHINE SERUMGuangzhou Fantesy Biotechnology Co.,Ltd062be336-2af4-10e2-e063-6294a90a480a2026-01-05WarningsExact identifier
application number: M020
sunscreen powderSUNSCREEN POWDERGuangzhou Fantesy Biotechnology Co.,Ltdfae8ecaf-7a9c-902b-e053-6394a90a5f312026-01-05WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 SunscreenDALLAS JAMES SKINCARE CO. SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd225faeec-4f96-e082-e063-6394a90a9a312026-01-05WarningsExact identifier
application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF30SKY AND SOL SUNSCREEN SPF30Guangzhou Fantesy Biotechnology Co.,Ltd1d917329-dea2-e792-e063-6294a90a0a0d2026-01-05WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF50SKY AND SOL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd1c699b06-c156-b0da-e063-6294a90a947d2026-01-05WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64768-2924-164768292401100 mL in 1 TUBE (64768-2924-1) 100 ml2019-11-010000-00-00NoNoCurrent
64768-2924-264768292402500 mL in 1 BOTTLE, PUMP (64768-2924-2) 500 ml2020-07-230000-00-00NoNoCurrent
64768-2924-364768292403325 mL in 1 BOTTLE, PUMP (64768-2924-3) 325 ml2022-03-070000-00-00NoNoCurrent