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 139 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AL0043600 Alba Botanica VE Herbal Healing Body	COLLOIDAL OATMEAL	The Hain Celestial Group, Inc.	60672feb-141f-651e-e053-2a91aa0af41d	2025-12-10	Warnings	Exact identifier application number: M020
UV Defense me. Matte Airy-Fit Sunscreen	ZINC OXIDE	MAGNIF CO., LTD	459f2b8d-453c-4dee-e063-6394a90a4509	2025-12-10	Warnings	Exact identifier application number: M020
RoC Hydration Plus SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	45a3e250-8195-344d-e063-6294a90ae681	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	bf3c1474-e353-63a5-e053-2a95a90a9b26	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	f161d754-0c32-2fbe-e053-2a95a90a6b47	2025-12-10	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242ff053-b8c0-4f90-e063-6294a90a7bb3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ef1f8-ad12-4f80-e063-6394a90a3e3c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e810d366-0c32-5b1c-e053-2a95a90a622e	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242b7d0e-82d8-793c-e063-6294a90a4aa3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	eb744367-f318-e1e2-e053-2a95a90a2cc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242faaed-e85a-a1d7-e063-6294a90aea92	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247d6c0e-8f88-faf0-e063-6394a90a10da	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Aekyung Industrial Co., Ltd.	1e9a5c77-7027-3b52-e063-6394a90ac0eb	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e8241828-17b2-96c5-e053-2a95a90a12e5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	1176181b-1331-ba68-e063-6394a90a961a	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247b56ad-4b61-8b6f-e063-6394a90af3b6	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247afcae-855e-3f69-e063-6394a90a4231	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	24306304-4d0d-c5f0-e063-6394a90afad5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Aekyung Industrial Co., Ltd.	1f9c7718-6fde-236c-e063-6394a90afa19	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3482855b-de85-a5a7-e063-6294a90a55ae	2025-12-09	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