Hello Sunday The One For Your Lips Clear Lip Balm SPF 50

Product NDC: 10596-806
11-digit product format: 105960806
Labeler code: 10596
Product ID: 10596-806_43d0f364-238d-9fae-e063-6394a90a4777
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: STICK
Route: TOPICAL
Labeler: Kao USA Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-01
Substance: OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength: 50; 30; 90; 73 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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10596-806-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10596-806-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10596-806-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10596-806-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10596-806-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10596-806-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10596-806-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10596-806-01	U	Excluded because listing certification expired	`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 For Your Lips Clear Lip Balm SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	50 mg/mL
AVOBENZONE	30 mg/mL
OCTOCRYLENE	90 mg/mL
HOMOSALATE	73 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
G63QQF2NOX	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
V06SV4M95S	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
0c92dfc3-782d-e11f-e063-6394a90a2f8a	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
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
10596-806-01	2025-11-17	C162847	48780-1	2cef2736-8679-d83d-e063-dadaa90ab31f	Hello Sunday The One For Your Lips Clear Lip Balm SPF 50
10596-806-01	2025-01-30	C162847	48780-1	2cef2736-8679-d83d-e063-dadaa90ab31f	Hello Sunday The One For Your Lips Clear Lip Balm SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10596-806-01	Hello Sunday The One For Your Lips Clear Lip Balm SPF 50	15 mL in 1 TUBE	STICK	15		2
10596-806-01	Hello Sunday The One For Your Lips Clear Lip Balm SPF 50	1 in 1 CARTON	STICK	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10596-806	HELLO SUNDAY THE ONE FOR YOUR LIPS CLEAR LIP BALM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [KAO USA INC.]	1	Current NDC, 2 package rows	20240201_0c92dfc3-782d-e11f-e063-6394a90a2f8a.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 220 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Superactive Moisturizer SPF 50 Brightening SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	4ff8525a-4526-4acf-86c7-88f1f1073274	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Unflavored	LIP BALM SPF15	LS Promotions Inc	3131632d-735c-6688-e063-6294a90a0239	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Chocolate Sundae flavored	LIP BALM SPF15	LS Promotions Inc	3142f352-ee65-47b5-e063-6394a90ada57	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Pina Colada flavored	LIP BALM SPF15 PINA COLADA FLAVORED	LS Promotions Inc	31440153-e7ca-1327-e063-6294a90a562c	2025-03-26	Warnings	Exact identifier application number: M020
CVS Health Sport 100 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	0a245b1b-eaf6-7011-e063-6294a90ab68f	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Apple Pie flavored	LIP BALM SPF15 APPLE PIE FLAVORED	LS Promotions Inc	3145bd6d-0ece-e9d5-e063-6294a90afb9d	2025-03-26	Warnings	Exact identifier application number: M020
HEB Glow 40 Tinted Sunscreen Face Primer	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B.	3146bcd9-d562-9ba6-e063-6294a90a37aa	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	3146fb5f-1fb5-f09f-e063-6294a90a6206	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Glow Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	31473cc9-08f5-39e3-e063-6294a90aa499	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	314776a8-a562-3dd2-e063-6394a90ab1b9	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	31478f5a-88f4-4b01-e063-6394a90a04b7	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	3147c08f-c3f2-aef1-e063-6294a90a5c44	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mangonada Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	3147ef18-9029-6d5b-e063-6394a90acee0	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	31487bad-a756-9050-e063-6394a90acacc	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40	ZINC OXIDE	Trader Joe's Company	3148c00f-21bb-c05f-e063-6394a90af0e8	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314b8147-fe7a-0698-e063-6394a90a872c	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314bcf42-ca01-0fa5-e063-6294a90a5fc8	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	1e5d494b-dccf-4ba1-89de-0bb4ba5b8d38	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Murad, LLC	ac6163fb-dbc1-432f-a590-86d31c93b29b	2025-03-26	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral Medium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e17dc640-30e9-441b-a212-ef1508af7944	2025-03-25	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
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10596-806-01	10596080601	1 TUBE in 1 CARTON (10596-806-01) / 15 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 One For Your Lips Clear Lip Balm SPF 50	Kao USA Inc.	2025-11-17	HUMAN OTC DRUG LABEL	2
Hello Sunday Bestseller Daily SPF Duo	Kao USA Inc.	2025-01-31	HUMAN OTC DRUG LABEL	2