Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50

Product NDC: 10596-801
Requested package NDC: 10596-801-01
11-digit product format: 105960801
Labeler code: 10596
Product ID: 10596-801_2d0825f9-54a7-7081-e063-6394a90a37ae
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; 90; 73; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10596-801	10596-801-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10596-801	10596-801-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10596-801	10596-801-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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
Listing expiration: 2026-12-31

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

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 115 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c00301-ee41-333c-e063-6294a90a61d5	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c078fa-05f9-ad80-e063-6394a90af3bb	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c108f6-a928-0a54-e063-6394a90ae686	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0ccca-c993-181e-e063-6294a90a7ae6	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0a55d-16d3-086a-e063-6394a90a30cf	2025-12-16		Exact identifier application number: M020
Eucerin Radiant Tone	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	2611e0cb-d56d-6ea1-e063-6294a90a745b	2025-12-16	Warnings	Exact identifier application number: M020
Really Great Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c1341d-fbf5-56a5-e063-6294a90aa045	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	KLOE SALON LLC	36c23c07-2011-3ddb-e063-6294a90a76e9	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sun Defense	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c465ea-979b-9474-e063-6394a90ab3f8	2025-12-16		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c4a27b-96e9-4f30-e063-6294a90a5655	2025-12-16		Exact identifier application number: M020
Mineral Sunscreen Non Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SAN JOSE MEDICAL SPA	37ef19e5-1775-a8d5-e063-6394a90acaef	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	BABYFACE LLC	36d69eb5-59b4-14a0-e063-6394a90a0a49	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d6141c-6967-d779-e063-6294a90af0a7	2025-12-16		Exact identifier application number: M020
Replenishing Daily Sunscreen	ZINC OXIDE	BABYFACE LLC	36d773d7-349d-68c1-e063-6394a90aff1e	2025-12-16		Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d44158a-44b3-5a3d-e063-6294a90a1f16	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light-Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d53071f-0275-d00c-e063-6294a90afcca	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d550967-25af-3e7a-e063-6394a90a2c79	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium-Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d57790c-22cf-08aa-e063-6394a90aeac0	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d5813e8-a219-db90-e063-6294a90a6ca7	2025-12-16	Warnings	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ESTHETIC ACADEMY LLC	36c043e0-fd6c-5f7a-e063-6294a90a8899	2025-12-16		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	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	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50	Kao USA Inc.	2025-01-31	HUMAN OTC DRUG LABEL	3