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 54 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCaf052521-bfa6-4142-a10b-ef51f474a0772026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLC42647444-93a3-4d2c-9bfc-91621fd098f72026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCa4b9d7c0-dc09-4f0e-8b65-90ba180552bf2026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
application number: M020
Round Lab Birch Juice Mother s Day Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4cf03092-7886-ffa1-e063-6294a90a2aad2026-03-13WarningsExact identifier
application number: M020
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra lightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEL'Oreal USA, Inc.dad00eee-92cd-7610-e053-2a95a90a1fac2026-03-13WarningsExact identifier
application number: M020
VITARAN REJUVENA SUNCAREALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATEBR PHARM CO. , Ltd.4cb7af72-49f6-0738-e063-6394a90a79eb2026-03-12WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4cd0a8a7-11aa-e168-e063-6394a90a2ff22026-03-12WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEVi-Jon, LLC3da4706e-7c1a-435e-9603-e9aa984320182026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC53806657-7b4d-45ff-a75b-9340dcd8140e2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC08237b4c-4e5c-4b12-9510-2f8d64ab7f3a2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 FairfaxZINC OXIDETower 28108851ac-3812-4c02-a04a-9f9a7f529ed62026-03-12WarningsExact identifier
application number: M020
DIY Booster SPF 30 Facial Serum UnscentedOCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDEAndalou naturalsebaf5ef7-84aa-4cb1-a701-2e0d0fd357df2026-03-12WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation INC.f268fb1c-d7c2-f2f9-e053-2995a90a9e222026-03-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
application number: M020
CENTELLA SUNSCREEN CreamZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd4cbac4e9-7540-f703-e063-6394a90ad8082026-03-11WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-FreeZINC OXIDECOOLA LLC4cad89a5-325c-b3c2-e063-6294a90ac2252026-03-10WarningsExact identifier
application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 SensitiveAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4caf2ab5-76cb-4b0f-e063-6294a90a233e2026-03-10WarningsExact 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