FDA.reportPublic FDA data

Hello Sunday The Everyday One Face Moisturiser SPF 50

Product NDC
10596-802
Requested package NDC
10596-802-01
11-digit product format
105960802
Labeler code
10596
Product ID
10596-802_26ba9461-aa37-9d09-e063-6394a90a29ae
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; 100; 70; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Everyday One Face Moisturiser SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL
HOMOSALATE70 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
0c7e1aa2-7054-435d-e063-6394a90a2d08Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-802-01Hello Sunday The Everyday One Face Moisturiser SPF 501 in 1 CARTONEMULSION12
10596-802-01Hello Sunday The Everyday One Face Moisturiser SPF 5050 mL in 1 BOTTLEEMULSION502
10596-802-02Hello Sunday The Everyday One Face Moisturiser SPF 501.5 mL in 1 PACKETEMULSION1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-802HELLO SUNDAY THE EVERYDAY ONE FACE MOISTURISER SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]2Current NDC, 3 package rows20241115_0c7e1aa2-7054-435d-e063-6394a90a2d08.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 251 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d338ec2-dca0-e032-e063-6394a90a69aa2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752d79d-5d82-0367-e063-6394a90a4f1c2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d33888d-20b3-f912-e063-6394a90a25dc2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d3379ba-465c-a889-e063-6394a90aaf232024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a0-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0751b356-607f-f3cb-e063-6294a90a40922024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cace-1b3e-e063-6394a90afe5d2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION07530636-cd21-3022-e063-6394a90a89d62024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752753e-cac9-9166-e063-6394a90a4d8d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06ad3c09-9f1b-b25c-e063-6294a90aebe12024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c57ff5-7013-d35f-e063-6394a90a6ee22024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b29-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44de-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44ef-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a3-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-802-01105960802011 BOTTLE in 1 CARTON (10596-802-01) / 50 mL in 1 BOTTLE1 bottle2024-02-01NoNoCurrent