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 159 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0e905f47-a1d8-4c5a-8247-d7328d2cb4af2025-11-21WarningsExact identifier
application number: M020
SPF 50 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inca22baebd-1f4d-6eae-e053-2a95a90afe512025-11-21WarningsExact identifier
application number: M020
Everyday Sun DefenseZINC OXIDEHommerejuvenate, Inc.05aa1a1a-9e4f-2781-e063-6394a90aef6b2025-11-21WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEWILD CHILD LABORATORIES PTY LTDdca2f4ce-1a3a-707e-e053-2995a90abad72025-11-21WarningsExact identifier
application number: M020
innisfree Daily UV Defense SunscreenAVOBENZONE, HOMOSALATE, AND OCTISALATE LOTIONInnisfree Corporation0e9b6697-28a3-f69f-e063-6394a90a9d112025-11-20WarningsExact identifier
application number: M020
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
application number: M020
Anti-Aging Complex Eye Treatment Merle NormanOCTINOXATE, ZINC OXIDEMerle Norman Cosmetics, Inc13381b0d-52f6-4736-b2bf-faf34d5028a82025-11-20WarningsExact identifier
application number: M020
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact identifier
application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDENorwex Usa, Inc.440bd831-ee0b-b527-e063-6294a90a93332025-11-20WarningsExact identifier
application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie RepellantZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca866e-adc3-5a4f-e063-6394a90a1d1d2025-11-20WarningsExact identifier
application number: M020
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50ZINC OXIDESunkissed By Heaven, LLC09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d2025-11-19WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
application number: M020
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
application number: M020
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.03b0f2ee-526b-4513-b70a-2918ad322b5e2025-11-19WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact 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