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 210 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	afa2d42e-b54d-4843-b313-0c44fe5c5d52	2025-06-06	Warnings	Exact identifier application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30	ZINC OXIDE	Andalou naturals	9314e4fc-ba3e-480e-a005-b8928130ed70	2025-06-06	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac	2025-06-05	Warnings	Exact identifier application number: M020
Body Glove Sunscreen SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	SCUBASCREEN LLC	1d7a960c-4387-44dc-8d4e-881e21a8ae2e	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36d65cb2-c2e7-06d7-e063-6394a90a3822	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36d747fb-b973-5611-e063-6394a90ac661	2025-06-05	Warnings	Exact identifier application number: M020
Non Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d7c8b3-554f-78d9-e063-6394a90a80f3	2025-06-05		Exact identifier application number: M020
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d80422-943f-3aba-e063-6294a90afb59	2025-06-05		Exact identifier application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	f8e178d6-058c-462a-8e59-6721f28ad040	2025-06-05	Warnings	Exact identifier application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	adcd6881-fa25-4312-95e5-5b47102aa6b9	2025-06-05	Warnings	Exact identifier application number: M020
Mineral Moisture Defense SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	05ad73f3-a4e8-4f78-8212-3e8e3bda988c	2025-06-05	Warnings	Exact identifier application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	6ce602bb-c1f4-43c1-ae61-0f05d7952db3	2025-06-05	Warnings	Exact identifier application number: M020
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	b8f08778-7e5e-4341-9a24-1ce57c6525c7	2025-06-05	Warnings	Exact identifier application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-X	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	812caa99-1e1e-4ab8-9f9a-fb3384c684dd	2025-06-05	Warnings	Exact identifier application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVB	AVOBENZONE, OCTOCRYLENE, AND OCTISALATE	MDSolarSciences	ba918886-d277-487a-be3b-bbe3e24343ad	2025-06-05	Warnings	Exact identifier application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	3e392af6-1401-4a2f-9ba4-e43f0fd0fca1	2025-06-05	Warnings	Exact identifier application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted Moisturizer	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	51bd8962-e85a-4964-9337-2ded6b7d8ac8	2025-06-05	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	0f23441c-2399-4a72-9f0a-420d25db78af	2025-06-05	Warnings	Exact identifier application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	36da165b-bc68-24ff-e063-6294a90a304f	2025-06-05	Warnings	Exact identifier application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Nemah, Inc.	36da2d94-fa90-b145-e063-6394a90a5854	2025-06-05	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