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 204 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Counter Beauty Daily Sheer Defense SPF 25	ZINC OXIDE	G2G Ventures, PBC	3a22d88b-cdb5-5656-e063-6294a90a5b77	2025-07-17	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 1	ZINC OXIDE	G2G Ventures, PBC	3a2676ed-087d-f957-e063-6294a90ad457	2025-07-17	Warnings	Exact identifier application number: M020
Sjolie Tanning SPF 30 Sunscreen	ZINC OXIDE	SJOLIE, INC.	3a283a09-2edb-f92c-e063-6294a90a82bd	2025-07-17	Warnings	Exact identifier application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	32889c1e-d539-4b36-b012-9789c4a8d642	2025-07-16	Warnings	Exact identifier application number: M020
GZE Tinted Sunscreen	ZINC OXIDE 3%	Guangzhou Yilong Cosmetics Co.,Ltd.	182612d8-76a4-44a1-e063-6394a90a8d5f	2025-07-15	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	089b798b-829f-aa86-e063-6294a90a8631	2025-07-15	Warnings	Exact identifier application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	8 PINE DESIGN LLC	982ada30-5f87-42c6-b9ea-fedd842aa09d	2025-07-15	Warnings	Exact identifier application number: M020
Amarte ULTRA VEIL Daily	SUNSCREEN	Amarte USA LLC	39e9ca98-d0e8-6b8f-e063-6394a90aa366	2025-07-15	Warnings	Exact identifier application number: M020
Amarte ULTRA VEIL BB Fair	SUNSCREEN	Amarte USA LLC	39e87950-4103-c2eb-e063-6394a90a0552	2025-07-15	Warnings	Exact identifier application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICK	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE	DONGDONGGURIMOO CO.,LTD.	39eea41c-8703-cf1f-e063-6394a90a5b1f	2025-07-14	Warnings	Exact identifier application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	4a8e7be0-97a6-ada5-e063-6294a90ae25a	2025-07-14	Warnings	Exact identifier application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	48980ef3-ebda-450e-9f15-effad27dec9a	2025-07-11	Warnings	Exact identifier application number: M020
KLARINA Sheer Mineral Sunscreen Blender SPF 50	ZINC OXIDE	KLARINA INC	081941e3-02da-43a2-bf6f-a6d0f053272f	2025-07-10	Warnings	Exact identifier application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ATHLETIC COSMETIC COMPANY LLC	f143a8e0-b32b-4b14-a6ae-f013627b484c	2025-07-10	Warnings	Exact identifier application number: M020
Venofye Orchard Bee Brilliance SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe	2025-07-10	Warnings	Exact identifier application number: M020
Touch Anti-Aging SPF 30 Moisturizer	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	Diractions Capital LLC	47ce948e-5848-43a1-880e-aeb78e9ad1b3	2025-07-10	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	06f2ced8-273e-454f-92b4-2846f6674b37	2025-07-10	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen 01	BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	398bb1f5-80ea-c589-e063-6294a90abefd	2025-07-09	Warnings	Exact identifier application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen	ENSULIZOLE	SICOS ET CIE	1ac50772-0bea-4a41-8300-03f65f0bed52	2025-07-09	Warnings	Exact identifier application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen	ENSULIZOLE	L'Oreal USA Products Inc	e74a8c43-ec70-4de1-b2b5-0e89e40bfb40	2025-07-08	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