Hello Sunday The One Thats a Serum Hydrating Serum SPF 45

Product NDC: 10596-803
11-digit product format: 105960803
Labeler code: 10596
Product ID: 10596-803_5fdc00ef-cdeb-28f6-e063-6294a90a836f
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: 2027-03-30
Substance: OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength: 50; 90; 70; 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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10596-803-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10596-803-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10596-803-01	`0efc9e666f02…`	`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 One Thats a Serum Hydrating Serum SPF 45

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	50 mg/mL
OCTOCRYLENE	90 mg/mL
HOMOSALATE	70 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c913096-c000-4336-e063-6394a90a560c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10596-803-01	2025-02-01	C162847	48780-1	2cef2736-87a8-d83d-e063-dadaa90ab31f	Hello Sunday The One That's a Serum Hydrating Serum SPF 45
10596-803-01	2025-02-01	C162847	48780-1	2cef2736-87a8-d83d-e063-dadaa90ab31f	Hello Sunday The One That's a Serum Hydrating Serum SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10596-803-01	Hello Sunday The One Thats a Serum Hydrating Serum SPF 45	1 in 1 CARTON	EMULSION	1		2
10596-803-01	Hello Sunday The One Thats a Serum Hydrating Serum SPF 45	30 mL in 1 BOTTLE	EMULSION	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10596-803	HELLO SUNDAY THE ONE THATS A SERUM HYDRATING SERUM SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]	2	Current NDC, 2 package rows	20250202_0c913096-c000-4336-e063-6394a90a560c.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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Broad Spectrum SPF 30 Sun Stick	BROAD SPECTRUM SPF 30 SUN STICK	Raining Rose, Inc	a35a7973-443b-5247-e053-2a95a90a4459	2023-10-23	Warnings	Exact identifier application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip Balm	CRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c3aa41-c9a0-4f64-e053-2995a90a005e	2023-10-23	Warnings	Exact identifier application number: M020
Super Mint SPF 15 Broad Spectrum Lip Balm	SUPER MINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9626a2f-9931-78d2-e053-2995a90ac40f	2023-10-23	Warnings	Exact identifier application number: M020
Spearmint SPF 30 Broad Spectrum Lip Balm	SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b520dc-bae6-614f-e053-2995a90ae677	2023-10-23	Warnings	Exact identifier application number: M020
Citrus SPF 15 Broad Spectrum Lip Balm	CITRUS SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75d0651-6001-29ce-e053-2a95a90a967f	2023-10-23	Warnings	Exact identifier application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip Balm	COCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0d2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Vanilla SPF 30 Broad Spectrum Lip Balm	VANILLA SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7b542fa-b0c2-7b33-e053-2995a90a7119	2023-10-23	Warnings	Exact identifier application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip Balm	PINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	b7c6684f-1122-20c1-e053-2995a90ae6cf	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	28b3fdff-1986-4048-9ed5-a3d784a4014e	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi CC Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	65de3c45-8ec2-4d73-8a29-6203d3b47bd7	2023-10-23	Warnings	Exact identifier application number: M020
Farmasi BB Cream- MEDIUM 03	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	9102aa2f-0308-4985-b8a8-8e105047b61f	2023-10-23	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip Balm	CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75a42f6-27d1-e2cc-e053-2a95a90aa6da	2023-10-23	Warnings	Exact identifier application number: M020
Iced Pear SPF 15 Broad Spectrum Lip Balm	ICED PEAR SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8c4a0ec-e07e-1cda-e053-2a95a90a0f3f	2023-10-23	Warnings	Exact identifier application number: M020
Lemonade SPF 15 Broad Spectrum Lip Balm	LEMONADE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a8ffc32b-b758-0f8f-e053-2995a90adb62	2023-10-23	Warnings	Exact identifier application number: M020
Strawberry SPF 15 Broad Spectrum Lip Balm	STRAWBERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a902d590-0726-ad6f-e053-2995a90a1130	2023-10-23	Warnings	Exact identifier application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip Balm	ORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a9005cb1-ae1a-7736-e053-2995a90a28ea	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	f2f3601f-081a-4bae-e053-2a95a90a4fac	2023-10-23	Warnings	Exact identifier application number: M020
Neora Age IQ Invisi-Bloc Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Neora, LLC	82f48635-1dc4-8c0d-e053-2991aa0a60cc	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1	TITANIUM DIOXIDE	Amway Corp	7494fe09-40e0-4152-9974-a6e8a4d7f421	2023-10-22	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1	TITANIUM DIOXIDE	Amway Corp	cec51b88-a6b8-4b64-b3aa-830e712a3c8a	2023-10-22	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10596-803-01	10596080301	1 BOTTLE in 1 CARTON (10596-803-01) / 30 mL in 1 BOTTLE	1 bottle	2024-02-01	2027-03-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hello Sunday The One That's a Serum Hydrating Serum SPF 45	Kao USA Inc.	2026-11-09	HUMAN OTC DRUG LABEL	3