FDA.reportPublic FDA data

Hello Sunday The Mineral One Lightweight Serum SPF 50

Product NDC
10596-804
11-digit product format
105960804
Labeler code
10596
Product ID
10596-804_2d083748-82aa-f046-e063-6294a90aea80
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
EMULSION
Route
TOPICAL
Labeler
Kao USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
ZINC OXIDE
Active strength
175.2 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10596-804-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10596-804-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10596-804-010efc9e666f02…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
Hello Sunday The Mineral One Lightweight Serum SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE175.2 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
0c91894f-a40e-73e9-e063-6394a90ab807Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-804-012025-02-01C16284748780-12cef2736-77ab-d83d-e063-dadaa90ab31fHello Sunday The Mineral One Lightweight Serum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-804-01Hello Sunday The Mineral One Lightweight Serum SPF 501 in 1 CARTONEMULSION12
10596-804-01Hello Sunday The Mineral One Lightweight Serum SPF 5030 mL in 1 BOTTLEEMULSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-804HELLO SUNDAY THE MINERAL ONE LIGHTWEIGHT SERUM SPF 50 (ZINC OXIDE) EMULSION [KAO USA INC.]2Current NDC, 2 package rows20250202_0c91894f-a40e-73e9-e063-6394a90ab807.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 123 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
application number: M020
Protection E And C Lightly TintedZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bce44e-d9f1-9279-e063-6394a90a64532025-12-15Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
application number: M020
Glow ShieldZINC OXIDEKristina Lerner35be8766-1352-8967-e063-6294a90a896a2025-12-15Exact identifier
application number: M020
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
application number: M020
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
application number: M020
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d2fbeb-935b-f0a9-e063-6294a90acd792025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEJMSE Management, LLC36ec860f-2066-196c-e063-6294a90a21212025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d3262a-1d8d-2afa-e063-6294a90afd492025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d37c2e-abc0-6bda-e063-6294a90a8fc32025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-804-01105960804011 BOTTLE in 1 CARTON (10596-804-01) / 30 mL in 1 BOTTLE1 bottle2024-02-01NoNoCurrent