Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50

Product NDC
10596-801
11-digit product format
105960801
Labeler code
10596
Product ID
10596-801_2d0825f9-54a7-7081-e063-6394a90a37ae
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
EMULSION
Route
TOPICAL
Labeler
Kao USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
50; 90; 73; 30 mg/mL; mg/mL; mg/mL; 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 packagepackage10596-801-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10596-801-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10596-801-010efc9e666f02…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 Invisible One Sunscreen Plus Primer SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE90 mg/mL
HOMOSALATE73 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c7ce5b9-5ab4-d845-e063-6394a90afa76Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
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
10596-801-012025-02-01C16284748780-12cef2736-a974-d83d-e063-dadaa90ab31fHello Sunday The Invisible One Sunscreen Plus Primer SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-801-01Hello Sunday The Invisible One Sunscreen Plus Primer SPF 501 in 1 CARTONEMULSION13
10596-801-01Hello Sunday The Invisible One Sunscreen Plus Primer SPF 5050 mL in 1 TUBEEMULSION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-801HELLO SUNDAY THE INVISIBLE ONE SUNSCREEN PLUS PRIMER SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]3Current NDC, 2 package rows20250202_0c7ce5b9-5ab4-d845-e063-6394a90afa76.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 109 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
application number: M020
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
application number: M020
tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a1edd-56e1-55f0-e063-6294a90a45a62025-12-17Exact identifier
application number: M020
non-tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a8c8d-df84-e568-e063-6394a90aaff12025-12-17Exact identifier
application number: M020
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
application number: M020
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
application number: M020
ULTRA SILK PROTECTION SUNSCREENZINC OXIDESKINFINITY383ea760-d55e-a32a-e063-6294a90aa3d22025-12-17Exact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f67134c-88e8-8513-e063-6294a90aaf5a2025-12-17WarningsExact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f66d2ae-00e7-608c-e063-6294a90a49c62025-12-17WarningsExact identifier
application number: M020
Bella Blue Skin Care Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f663fe5-fdfe-d793-e063-6394a90a4f0b2025-12-17WarningsExact identifier
application number: M020
Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3aadc018-edbb-033b-e063-6394a90afbe72025-12-17WarningsExact identifier
application number: M020
Non-Tinted Daily Mineral ShieldZINC OXIDESIGNATURE MED SPA MT LLC3ab0298d-b2d0-591e-e063-6394a90a31772025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3ccea6c0-8c27-6b26-e063-6294a90a09312025-12-17WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEJKH Aesthetics LLC369c1d16-5980-e1dc-e063-6394a90a31042025-12-17Exact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEESTHETICS BY MINDY LLC3d5ab3f6-10b9-2a21-e063-6294a90a34282025-12-17WarningsExact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364cafdd-fe86-cb23-e063-6394a90afb092025-12-17Exact identifier
application number: M020
Royal ScreenZINC OXIDEQUEENIES BEAUTY LLC364d2231-3db3-0a59-e063-6394a90a67772025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-801-01105960801011 TUBE in 1 CARTON (10596-801-01) / 50 mL in 1 TUBE1 tube2024-02-01NoNoCurrent