EIGHT HOUR LIP PROTECTANT SPF 15

Product NDC: 10967-692
11-digit product format: 109670692
Labeler code: 10967
Product ID: 10967-692_2a0ac71c-e567-5ff9-e063-6394a90a4807
Type: HUMAN OTC DRUG
Nonproprietary name: PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: REVLON
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-11-01
Substance: AVOBENZONE; OCTINOXATE; OXYBENZONE; PETROLATUM
Active strength: 2; 7.49475; 3; 30.99938 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 LIP PROTECTANT SPF 15
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	2 mg/g
OCTINOXATE	7.49475 mg/g
OXYBENZONE	3 mg/g
PETROLATUM	30.99938 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup
4T6H12BN9U	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
2a0ac6aa-0315-d79e-e063-6294a90a9c53	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10967-692-61	EIGHT HOUR LIP PROTECTANT SPF 15	3.7 g in 1 CARTRIDGE	LIPSTICK	3.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10967-692	EIGHT HOUR LIP PROTECTANT SPF 15 (PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE) LIPSTICK [REVLON]	1	Current NDC, 1 package rows	20241226_2a0ac6aa-0315-d79e-e063-6294a90a9c53.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 57 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bath and Body Works SPF At The Beach	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c315bdb-dc33-1737-e063-6294a90a31a4	2026-03-02	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d02c8d-cdc8-b8d6-e063-6294a90ad9e4	2026-03-02	Warnings	Exact identifier application number: M020
Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATE	Old East Main Co.	a460e512-f268-4941-beb6-29df10fdbb3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Tanning Sunscreen SPF 15	AVOBENZONE HOMOSALATE OCTISALATE	Old East Main Co.	42258ebe-e3cc-4d70-e063-6294a90a9651	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE	Old East Main Co.	db876d34-1af9-4e0a-9e9a-32a8b00e9405	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Old East Main Co.	2ea288fe-815d-4568-9592-55ea428448fa	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	cea1c223-c9d4-42ac-8c5b-c0ca647d57a1	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Old East Main Co.	00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	8f4a6a31-2fae-42fe-924f-10237c59e791	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ef48288b-533f-4924-ba12-fc8cb83643d4	2026-03-02	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	e6976bf4-ad77-4953-858f-4a0ec7f4300c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	b3d2da09-d9c9-4c27-82fe-a434ece2f099	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ba9331ef-3744-4072-80a2-af95c6f7ee05	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	1a53d8d5-e650-4825-8a3b-7cf42c36e3e5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	086dfda5-9fe7-46b4-9964-4977b86cfdd5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	ce9a2139-c5c2-43e2-bd51-1f14ace594d9	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M020
Bask SPF 40 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Surfside Skincare, Inc. dba Bask Suncare	49a30877-e39f-46a3-e063-6394a90a8dd2	2026-03-02	Warnings	Exact identifier application number: M020
Sunscreen SPF30	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	f6014a97-12d3-4f42-86de-866a206c6c06	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS VANILLA	Epic Laboratories, LLC	02488aad-28be-4ffb-e063-6294a90ad01e	2026-03-02	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10967-692-61	10967069261	3.7 g in 1 CARTRIDGE (10967-692-61)	3.7 g	2021-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SPF 15	REVLON	2024-12-24	HUMAN OTC DRUG LABEL	1