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 305 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrator Plus SPF 30	BROAD SPECTRUM	CP Skin Health Group, Inc.	b6c0db82-9fba-6216-e053-2a95a90a7560	2024-02-14	Warnings	Exact identifier application number: M020
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O	OCTINOXATE, TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10f7ec01-541b-a15a-e063-6294a90aa9df	2024-02-09	Warnings	Exact identifier application number: M020
Sunscreen	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Safetec of America, Inc.	754186c8-3c88-40a0-a4e3-35e3ea9d1b4c	2024-02-08	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM SPF-50 Blocked Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	2cf40d87-626b-4309-8f13-fd980161c62f	2024-02-07	Warnings	Exact identifier application number: M020
Equate Sunscreen for All Skin Tones SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WAL-MART INC.	1062060a-a5c7-1805-e063-6294a90ab802	2024-02-02	Warnings	Exact identifier application number: M020
Equate Kids Sunscreen Broad Spectrum SPF 50 Equate	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WAL-MART INC.	10631036-0fa6-b3ee-e063-6294a90af7aa	2024-02-02	Warnings	Exact identifier application number: M020
Death Tan SPF 50 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Derma Care Research Labs, LLC	106ab5e2-e134-b81d-e063-6294a90a5bca	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour	TITANIUM DIOXIDE	COOLA, LLC	edfda0f5-0f72-5cc7-e053-2a95a90ae38d	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush	ZINC OXIDE	COOLA, LLC	edc6754e-dabb-5bff-e053-2a95a90a7390	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip	ZINC OXIDE	COOLA, LLC	ee01f936-81a9-a54d-e053-2a95a90a5227	2024-02-02	Warnings	Exact identifier application number: M020
toty Solaria Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e9d590d8-e71a-0715-e053-2a95a90a5acf	2024-02-01	Warnings	Exact identifier application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50	ZINC OXIDE	LG H&H Co., Ltd.	10d343c8-f0c1-6b90-e063-6294a90a24ba	2024-02-01	Warnings	Exact identifier application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50	ZINC OXIDE	fmg Co.Ltd	10d401af-fd92-d82a-e063-6294a90a9f7f	2024-02-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	18f05adb-43a8-47e5-bc5a-fbf3209d0a44	2024-01-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	03593e3c-c98a-43af-82bc-10331e23342c	2024-01-31	Warnings	Exact identifier application number: M020
ATOMY SUN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	ATOMY CO., LTD.	bdf0a11d-3563-4b09-a430-f031709cb3f3	2024-01-30	Warnings	Exact identifier application number: M020
ATOMY DERMA CALMING SUN	TITANIUM DIOXIDE	ATOMY CO., LTD.	fd5fc3ba-6e7c-4e48-8e65-47c03141df45	2024-01-30	Warnings	Exact identifier application number: M020
EltaMD UV Lip Balm SPF31	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health, Inc	0ec70f0a-cda4-4953-b056-e1e6e9921e5b	2024-01-25	Warnings	Exact identifier application number: M020
BBW SPF 35 Natural Lip Balm	BBW SPF 35 NATURAL LIP BALM	Autumn Harp	0f8b024c-c481-951b-e063-6394a90ac63c	2024-01-22	Warnings	Exact identifier application number: M020
Bath and Body Works SPF 35 Natural Lip Balm	BATH AND BODY WORKS SPF 35 NATURAL LIP BALM	Bath and Body Works, Inc.	0f8dab80-c84f-ffbd-e063-6294a90a317e	2024-01-22	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