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 208 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel	OCTINOXATE, ZINC OXIDE	BEL STAR S A	c4f95c1b-acbe-4bb7-e053-2995a90a9120	2025-06-19	Warnings	Exact identifier application number: M020
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N	OCTINOXATE, ZINC OXIDE	Bel Star S.A.	d22fde8a-ba14-2cc7-e053-2a95a90a0e53	2025-06-19	Warnings	Exact identifier application number: M020
Correct and Protect Serum Broad Spectrum SPF 45	ZINC OXIDE	Murad, LLC	dba6e01b-a8ec-4812-bbe0-e418bb067032	2025-06-19	Warnings	Exact identifier application number: M020
Truffoire Truffle Brightening	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	e3068ecf-0bee-4e8a-a439-4bb707a2845d	2025-06-18	Warnings	Exact identifier application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	383de98b-65b5-4398-a876-87367dc01d0b	2025-06-18	Warnings	Exact identifier application number: M020
CB Multi-Active Moisturizer with SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	d9557a6c-78e9-4b01-8a4b-e0eceb511c4e	2025-06-18	Warnings	Exact identifier application number: M020
1000 Roses CC Color plus Correct Sheer Beige SPF 30	ZINC OXIDE	Andalou naturals	2e7f3570-f710-41dd-95a0-7c0613b317a2	2025-06-17	Warnings	Exact identifier application number: M020
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	SKIN CARE BY SCOTTIE LLC	a9afa58c-f438-48c6-bd30-eda41334df74	2025-06-16	Warnings	Exact identifier application number: M020
Wellage Real Hyaluronic Watery Glow Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hugel, Inc.	37aa2f7b-afa4-5cc9-e063-6294a90ae741	2025-06-16	Warnings	Exact identifier application number: M020
Dermaka Sunscreen SPF 42, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9a967cd1-9eec-4255-b14b-ac2e33e4dbf0	2025-06-16	Warnings	Exact identifier application number: M020
Elizabeth Arden Eight Hour Hydraplay SPF 40	OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE	Revlon Consumer Products Corp	2cc74177-0f62-106e-e063-6394a90a6e28	2025-06-16	Warnings	Exact identifier application number: M020
BALI BODY SPF15 BRONZE SHIMMERING TANNING	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	240d4d80-641c-ac57-e063-6394a90abe75	2025-06-16	Warnings	Exact identifier application number: M020
Environ Skin Care RAD Shield Mineral Sunscreen SPF 30	SUNSCREEN	ENVIRON SKIN CARE (PTY) LTD	3778547e-11a8-3b30-e063-6394a90ab5b1	2025-06-13	Warnings	Exact identifier application number: M020
Voupre Age Defense	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	8dfaa076-c62a-47ee-bc5d-75360416fa1a	2025-06-13	Warnings	Exact identifier application number: M020
Instantly Dry	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37624bf6-4949-1b10-e063-6294a90ac488	2025-06-12		Exact identifier application number: M020
silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVB	ZINC OXIDE AND HOMOSALATE	OneKind.25	d739bc43-d76e-9258-e053-2a95a90a3d2c	2025-06-12	Warnings	Exact identifier application number: M020
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18	HOMOSALATE, OCTISALATE, AND AVOBENZONE	Andalou naturals	0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f	2025-06-11	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	374e770f-75b5-08d0-e063-6394a90adf92	2025-06-11	Warnings	Exact identifier application number: M020
Reflecting Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	Helande, LLC	3750f04b-7f9f-8793-e063-6294a90a9143	2025-06-11	Warnings	Exact identifier application number: M020
Vitamin C BB Beauty Balm Sheer Tint SFP 30	ZINC OXIDE	Andalou naturals	f423b484-2119-4c95-a0da-77bcd07303eb	2025-06-11	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