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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BB Tint 30 BS SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	1212448c-db88-26e6-e063-6294a90a3b9e	2024-02-23	Warnings	Exact identifier application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30	ZINC OXIDE	Allure Labs	11fce5ec-66e8-9eac-e063-6394a90aaf3a	2024-02-22	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEP	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	bf31d19d-9520-4ac0-a4fd-2c285545f1b8	2024-02-20	Warnings	Exact identifier application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	2c0964cd-607c-4219-b66e-cc99ada80434	2024-02-20	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHT	HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE	Laboratoires Clarins	6259442e-0c39-4887-8083-89253b64b5ff	2024-02-20	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%	Meijer	074b6340-0482-ab05-e063-6294a90adedb	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	11c37acc-abb8-8c38-e063-6294a90a7932	2024-02-19	Warnings	Exact identifier application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	11c461f7-0f34-65ff-e063-6294a90a3da7	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c61b92-89f4-692f-e063-6394a90a69cd	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c651e2-072e-770e-e063-6394a90ad6fa	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	11c65e7f-fe11-8115-e063-6394a90a8594	2024-02-19	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11c6cf95-8923-af79-e063-6294a90a4f44	2024-02-19	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	118842ce-9d9b-80ce-e063-6394a90ab986	2024-02-16	Warnings	Exact identifier application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	11894c1d-c199-dfc0-e063-6394a90a3f15	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	711aa92c-81b0-42e4-b83f-9ce95116ec03	2024-02-16	Warnings	Exact identifier application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b8bc0021-bb4d-45f2-a570-3f2e61edf21d	2024-02-16	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Meijer	075dddd5-46ea-282a-e063-6294a90a28fd	2024-02-15	Warnings	Exact identifier application number: M020
Sheet SPF 30 Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma Inc.	bbb5b87c-d641-3ba2-e053-2a95a90a0f70	2024-02-14	Warnings	Exact identifier application number: M020
sheer tint SPF 45	BROAD SPECTRUM	CP Skin Health Group, Inc.	b7c5cedd-ff68-74de-e053-2a95a90a3796	2024-02-14	Warnings	Exact identifier application number: M020
Weightless Protection SPF 45	SUNSCREEN BROAD SPECTRUM	CP Skin Health Group, Inc.	b6bee26d-bffd-a8ee-e053-2a95a90affc5	2024-02-14	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