ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR

Product NDC: 10967-676
11-digit product format: 109670676
Labeler code: 10967
Product ID: 10967-676_2a85bd43-4196-6ed7-e063-6294a90a84d4
Type: HUMAN OTC DRUG
Nonproprietary name: LIP PROTECTANT
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: REVLON CONSUMER PRODUCTS CORP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-01
Substance: PETROLATUM; OCTINOXATE; OXYBENZONE; AVOBENZONE
Active strength: 1.147; .2775; .111; .074 g/3.7g; g/3.7g; g/3.7g; g/3.7g
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: ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	1.147 g/3.7g
OCTINOXATE	.2775 g/3.7g
OXYBENZONE	.111 g/3.7g
AVOBENZONE	.074 g/3.7g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	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
f3a6fe29-7af7-bfb1-e053-2a95a90a0101	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
10967-676-64	ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR	3.7 g in 1 TUBE	LIPSTICK	3.7		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10967-676	ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR (LIP PROTECTANT) LIPSTICK [REVLON CONSUMER PRODUCTS CORP]	2	Current NDC, 1 package rows	20250101_f3a6fe29-7af7-bfb1-e053-2a95a90a0101.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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	Exact identifier application number: M016

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10967-676-64	10967067664	3.7 g in 1 TUBE (10967-676-64)	3.7 g	2023-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SUNSCREEN SPF 15- CLEAR	REVLON CONSUMER PRODUCTS CORP \| REVLON, INC	2024-12-30	HUMAN OTC DRUG LABEL	2