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 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	10596-801-01	`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	10596-801-01	`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	10596-801-01	`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 Invisible One Sunscreen Plus Primer SPF 50

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	50 mg/mL
OCTOCRYLENE	90 mg/mL
HOMOSALATE	73 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
0c7ce5b9-5ab4-d845-e063-6394a90afa76	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
124351b2-6dbf-42d0-9ea7-f0e299215f9a	Product name	1	20210115
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
10596-801-01	2025-02-01	C162847	48780-1	2cef2736-a974-d83d-e063-dadaa90ab31f	Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50
10596-801-01	2025-02-01	C162847	48780-1	2cef2736-a974-d83d-e063-dadaa90ab31f	Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10596-801-01	Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	1 in 1 CARTON	EMULSION	1		3
10596-801-01	Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	50 mL in 1 TUBE	EMULSION	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10596-801	HELLO SUNDAY THE INVISIBLE ONE SUNSCREEN PLUS PRIMER SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) EMULSION [KAO USA INC.]	3	Current NDC, 2 package rows	20250202_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 280 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented	ZINC OXIDE	H.E.B.	f58ed2f9-67c3-ce91-e053-2995a90a1229	2024-10-15	Warnings	Exact identifier application number: M020
HEB Shimmer Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5930029-4c96-2576-e053-2995a90a7bed	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5a3313e-4935-1ce3-e053-2a95a90a6ad1	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b6caf2-ebff-79fb-e053-2995a90ac2f8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f59461e3-9521-6a7b-e053-2a95a90a73b8	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2c266-6fc9-21ae-e053-2995a90aec0e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pink Peony Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b7172a-b8fc-0d11-e053-2a95a90a9f73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Peach Bellini Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cbac04-361f-9226-e053-2995a90a2d7b	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Cucumber Water Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5d933cf-3461-8b03-e053-2a95a90ad79f	2024-10-15	Warnings	Exact identifier application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B	f6ce4ea0-d92f-368c-e053-6294a90a2a81	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 White Gardenia Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE	H.E.B	f5a2702c-5451-58a1-e053-2a95a90adb8e	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5cb5f9a-6691-37c3-e053-2a95a90a9af0	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Rosewater Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5db7ec6-0e9b-7044-e053-2a95a90a1e48	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Pomegranate Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b48729-43d3-72b4-e053-2995a90a9d85	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b682aa-a194-09ff-e053-2a95a90ade73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b755af-2bd3-33cf-e053-2a95a90a9961	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Watermelon Serbert Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b77cc0-1ed5-c4ae-e053-2a95a90abc1a	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6e0db20-594b-30a8-e053-6394a90a7164	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6dfe973-bd88-e0e4-e053-6394a90ac927	2024-10-15	Warnings	Exact identifier application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H-E-B	f6e29c93-9fd9-36c6-e053-6394a90a1747	2024-10-15	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
10596-801-01	10596080101	1 TUBE in 1 CARTON (10596-801-01) / 50 mL in 1 TUBE	1 tube	2024-02-01	2027-05-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	Kao USA Inc.	2026-11-09	HUMAN OTC DRUG LABEL	4