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 260 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	06245c8c-93e8-4ebb-bab0-3db64dc178b9	2024-12-09	Warnings	Exact identifier application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc7b0d17-d7c8-433f-e053-2995a90a477d	2024-12-09	Warnings	Exact identifier application number: M020
Sheer Zinc SPF 30	ZINC OXIDE	Allure Labs	b6b45dac-41d0-1b55-e053-2a95a90acf61	2024-12-09	Warnings	Exact identifier application number: M020
Broad Spectrum SPF30 Mineral Sunscreen	ZINC OXIDE	Allure Labs	dafc8e62-7c99-1f6d-e053-2995a90a7791	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Tinted Moisturizer SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	ed883d63-777c-e924-e053-2995a90a162a	2024-12-09	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Mahogany	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dcba05ff-7a68-c5c0-e053-2a95a90a6129	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Matte Moisturizer SPF 30	ZINC OXIDE AND HOMOSALATE	Allure Labs	f0fb1b69-53f2-efff-e053-2995a90af9d4	2024-12-09	Warnings	Exact identifier application number: M020
MD Restoring daily Defense Moisturizer SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs Inc	eb8e7109-b5eb-5cc1-e053-2995a90a486f	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF 30 Tinted	ZINC OXIDE	Allure Labs	f1761b09-9061-a052-e053-2a95a90a39c8	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF30	ZINC OXIDE	Allure Labs	f188669f-7b9f-6e01-e053-2995a90afa3c	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Clear Solar Gel SPF30	AVOBENZON, OCTISALATE AND OCTOCRYLENE	Allure LAbs	f19f6d9b-5249-27a6-e053-2a95a90a8a39	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted	ZINC OXIDE	Allure Labs	02e7fb00-2039-c4f8-e063-6294a90a418f	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted	ZINC OXIDE	Allure Labs	02f9c859-8d7d-5146-e063-6394a90a57b5	2024-12-09	Warnings	Exact identifier application number: M020
Quench and Protect Hydrating SPF30	ZINC DIOXIDE AND TITANIUM DIOXIDE	Allure Labs.	039e50c1-7b3d-d392-e063-6394a90a4b3c	2024-12-09	Warnings	Exact identifier application number: M020
Tinted Face Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	0d7300ee-adf4-41be-bb9f-257cd2986c0f	2024-12-06	Warnings	Exact identifier application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Beautcella Inc.	bad942d8-04da-31d2-e053-2a95a90a9275	2024-12-06	Warnings	Exact identifier application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	289b824f-bb0b-313e-e063-6394a90ab783	2024-12-06	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d840001-a648-df1b-e063-6294a90ab299	2024-12-06	Warnings	Exact identifier application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE, OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	1629f061-b8fc-4fda-8378-c64e164d41bd	2024-12-06	Warnings	Exact identifier application number: M020
Clear System Brightening Day Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	8cbc8fa4-469f-4fa3-bd8e-27e815989c3f	2024-12-06	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