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 firm2026-10-21
excluded packagepackage64768-292464768-2924-3DDiscontinued by firm2026-10-21

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 48 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simple Mineral Sunscreen SPF 50ZINC OXIDESimple Sunscreen LLCc38cb4fa-8b8d-4c2d-9c32-301e120db1a12026-04-06WarningsExact identifier
application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen CreamZINC OXIDEW.S. Badger Company, Inc.2a96c423-f4ad-0f07-e063-6394a90a39f82026-04-06WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC03fce792-bcbb-4848-bc87-8913ecbe07862026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC8937705d-b745-4b8c-bf9b-89e64a1e52b12026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab6773f-00e1-897a-e063-6294a90ab0b82026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEGuthy-Renker LLCeb1a9b67-b9e2-41f8-bc6d-df94b6a33ab82026-04-06WarningsExact identifier
application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUMHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENETIRTIR USA Inc.4ec04105-e54f-a82e-e063-6394a90a6c5a2026-04-05WarningsExact identifier
application number: M020
PRVWORA Ultra Defense SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECellarkbio Inc.50cf1d88-3e7e-47b7-816a-3d579bde0a6a2026-04-04WarningsExact identifier
application number: M020
EltaMD UV Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
application number: M020
Vacation SPF 30 ClassicSprayAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.da43d71d-733b-5700-e053-2a95a90a5dca2026-04-03WarningsExact identifier
application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30ZINC OXIDEAllure Labs4e93e64a-97ab-e0a5-e063-6294a90ad9502026-04-03WarningsExact identifier
application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
application number: M020
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
application number: M020
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
application number: M020
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light MediumZINC OXIDEIlia, Inc.4e7cc73c-d6c9-ecb0-e063-6394a90a922c2026-04-02WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact 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