FDA.reportPublic FDA data

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_5fdbd980-e385-a2c7-e063-6394a90aa7fa
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
Marketing end
2027-05-30
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
50; 90; 73; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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

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
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 273 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Cacao Tanning Oil SPF 15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03c0b83d-0d85-9e69-e063-6394a90a61422024-10-21WarningsExact identifier
application number: M020
ALDI LACURA KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCe34f37d7-02a5-0b72-e053-2a95a90acf832024-10-21WarningsExact identifier
application number: M020
Aldi Lacura Ultra Light Body SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7ac082c-def8-4379-e053-6294a90a57e32024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7bdc1f7-d961-4596-e053-6394a90a1d872024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7b2cf4e-468c-3406-e053-6394a90a21392024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7b32aa8-2e56-3725-e053-6294a90a18d22024-10-21WarningsExact identifier
application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50ZINC OXIDEBliss Products Holdings LLCf262e5a7-3c57-a6d8-e053-2995a90aacbc2024-10-21WarningsExact identifier
application number: M020
Berkley Jensen Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBJWCfbd65277-7aff-de19-e053-6394a90a94962024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC01bfe44c-655f-404c-981e-8d5f6728a7382024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLCaa612570-b70a-4910-8086-6634834beb702024-10-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf5bd673a-46e5-43d5-9d76-8ddc5da701462024-10-21WarningsExact identifier
application number: M020
Sun Bum Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLC6fcec9f9-bee0-4884-8c72-be273426f9162024-10-21WarningsExact identifier
application number: M020
sunscreenSKIN BARRIER SUN SHIELD SPF 30True Botanicals, Inc.d70eea23-7715-c17b-e053-2a95a90a839f2024-10-18WarningsExact identifier
application number: M020
First Aid Only SunX30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcme United Corporation24c22903-8911-81d9-e063-6394a90a108b2024-10-18WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c85e5094-d442-55a9-e053-2995a90aed122024-10-18WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.24c78897-3136-f24b-e063-6394a90aa80a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f451c472-1d9f-1fbc-e053-2995a90a114e2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenZINC OXIDEFruit Of The Earth, Inc.f4490608-6cce-90f3-e053-2995a90a49302024-10-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10596-801-01105960801011 TUBE in 1 CARTON (10596-801-01) / 50 mL in 1 TUBE1 tube2024-02-012027-05-30NoNoHistorical