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 254 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM	ZINC OXIDE	COSMAX USA, CORPORATION	298707d4-72ed-796f-e063-6294a90aa5cd	2024-12-18	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT	ZINC OXIDE	COSMAX USA, CORPORATION	29871c02-9adf-6266-e063-6394a90a20ab	2024-12-18	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM TAN	ZINC OXIDE	COSMAX USA, CORPORATION	29874029-24bf-b2ce-e063-6394a90acd4d	2024-12-18	Warnings	Exact identifier application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30	ZINC OXIDE	Babo Botanicals, Inc.	2990e4ff-5bdb-3008-e063-6294a90a9497	2024-12-18	Warnings	Exact identifier application number: M020
Tinted Lip Cream SPF 15	ZINC OXIDE	COSMAX USA, CORPORATION	29915354-4673-7444-e063-6294a90a0fd1	2024-12-18	Warnings	Exact identifier application number: M020
Mineral Lip Balm SPF-15	ZINC OXIDE	TUBBY TODD	4d938672-5302-4e47-a582-c3e6467008cb	2024-12-18	Warnings	Exact identifier application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30	ZINC OXIDE	Saltyface Natural Inc	f0cc7ce9-81b3-439f-b5ee-96138de54e78	2024-12-18	Warnings	Exact identifier application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	e999d752-6c00-459e-b6c3-d264c330597d	2024-12-18	Warnings	Exact identifier application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	f22626c1-0996-41d8-a2ec-3bf7491df657	2024-12-18	Warnings	Exact identifier application number: M020
Costa Sea Mineral Sunscreen SPF 50	ZINC OXIDE	COSTA SEA INC	841e1b3d-dbbc-4bb0-886a-fb2d077ae739	2024-12-18	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen All Mineral Active Ingredients	TITANIUM DIOXIDE AND ZINC OXIDE	KAS Direct LLC dba BabyGanics	247aae3d-1845-4dd8-b774-b9e8214809a2	2024-12-18	Warnings	Exact identifier application number: M020
Softlips Vanilla, Watermelon, Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	2235d029-157e-4a30-be90-605e6bc143fd	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow Ghost	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	42cf4623-0eb8-455a-b374-8e17e9336b92	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	0338c078-695d-4d4e-9e90-5a8a98d49524	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Pearl Plus Vanilla	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	107bcaa9-4347-4979-be44-35183a9ee67e	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Raspberry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	d18b4c19-0365-44ec-bea8-4328e537e0d8	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	03062f13-270d-49cf-8939-2349f12e9cba	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Vanilla Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	f733747a-ad1a-4222-baf1-69dcd90a3350	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Vanilla Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Marshmallow Ghost	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	8d55141d-5d6f-4eec-87dc-d3c808cf7a6a	2024-12-17	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