EIGHT HOUR NOURISHING LIP SPF 20

Product NDC: 10967-671
11-digit product format: 109670671
Labeler code: 10967
Product ID: 10967-671_471d7db4-fbd2-4509-e063-6394a90a02a6
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, AVOBENZONE
Dosage form: EMULSION
Route: TOPICAL
Labeler: REVLON
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-10-21
Substance: OCTINOXATE; AVOBENZONE
Active strength: 4; 3 mg/g; mg/g
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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10967-671-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10967-671-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10967-671-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10967-671-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10967-671-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10967-671-61	`cdf11ea48f46…`	`ba0047e9e063…`
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	10967-671-61	`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	10967-671-61	`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	10967-671-61	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10967-671-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10967-671-61	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10967-671-61	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10967-671-61	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10967-671-61	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10967-671-61	`1332a3947898…`	`d4bfe170f9cd…`

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: EIGHT HOUR NOURISHING LIP SPF 20
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	4 mg/g
AVOBENZONE	3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	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
b3c16e60-752d-6eba-e053-2995a90a2b20	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-12-29	ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
2023-07-28	ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
2022-02-09	ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
2022-01-28	ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10967-671-61	EIGHT HOUR NOURISHING LIP SPF 20	14.2 g in 1 TUBE, WITH APPLICATOR	EMULSION	14.2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10967-671	EIGHT HOUR NOURISHING LIP SPF 20 (OCTINOXATE, AVOBENZONE) EMULSION [REVLON]	2	Current NDC, Legacy NDC, 1 package rows	20220210_b3c16e60-752d-6eba-e053-2995a90a2b20.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 40 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f45f7953-c103-4900-e053-2a95a90ae399	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c888ce-3a3f-972b-e053-2a95a90a4fe3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKNI TINT	PML NYC, LLC	f4c44eb6-0a3d-2848-e053-2a95a90a58f3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8925c-ac54-43b1-e053-2995a90a916c	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8b011-5e1d-378c-e053-2a95a90a09cf	2026-04-18	Warnings	Exact identifier application number: M020
EltaMD UV Daily SPF40	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	d967b7d0-453a-4420-886a-70ecf46528d2	2026-04-17	Warnings	Exact identifier application number: M020
ELROEL Pang Pang Sun Cushion S7	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	256bf56f-aefa-47ce-890c-5a3896c11b92	2026-04-17	Warnings	Exact identifier application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE	Enprani Co., Ltd.	4fa30449-5332-1492-e063-6394a90a585f	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	3a43c7c0-7468-4b7a-95b9-f03e37f1b49b	2026-04-17	Warnings	Exact identifier application number: M020
FORGESKIN	MINERAL TALLOW SUNSCREEN	GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD	4fa7e67d-cfc5-9f73-e063-6394a90ada50	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	a251eb20-02e6-4b55-b969-c1bef2f9d732	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Pink	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6684d69a-89ff-41e8-81f0-3e2367811a18	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	bf24d081-85f7-4a26-9416-ecff1fe59dec	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	4a09a01a-404f-4b67-91e0-666153f550e8	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	cf7c4445-0382-47ab-aba9-b40d63e4f1cc	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	0e18d601-700a-4c1c-a434-22582253bd95	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ddb3aa5e-cd1a-4792-b1b1-3604b368e010	2026-04-17	Warnings	Exact identifier application number: M020
House of Colour Tinted Sunscreen SPF 50	ZINC OXIDE	House of Colour, Inc.	763f5534-cda1-43f2-8a37-1eaa6a43c2e8	2026-04-17	Warnings	Exact identifier application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick Sunlight	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	28c9f019-34fe-4568-ba35-38eb3c4cb19e	2026-04-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
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
10967-671-61	10967067161	14.2 g in 1 TUBE, WITH APPLICATOR (10967-671-61)	14.2 g	2020-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20	REVLON \| Englewood Lab. INC.	2025-12-29	HUMAN OTC DRUG LABEL	3