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
IngredientStrength
PETROLATUM1.147 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
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3a6fe29-7af7-bfb1-e053-2a95a90a0101Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-676-64ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR3.7 g in 1 TUBELIPSTICK3.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-676ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR (LIP PROTECTANT) LIPSTICK [REVLON CONSUMER PRODUCTS CORP]2Current NDC, 1 package rows20250101_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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016
Healing Hand CreamALLANTOINCarolina Cannabis Creations LLC3dd5887f-a26b-01ef-e063-6394a90a0c522025-09-02WarningsExact identifier
application number: M016
OKeeffes Skin Repair Body Cream Eczema ReliefCOLLOIDAL OATMEALThe Gorilla Glue Company/O'Keeffe's Company39e9ca98-d0e6-6b8f-e063-6394a90aa3662025-09-01WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3d379d5b-e939-9391-e063-6294a90a375c2025-08-25WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3d1fd588-8d16-509c-e063-6394a90ad0252025-08-24WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMY IMPORTS USA LLC3d2000da-a173-1fc3-e063-6294a90ad3a92025-08-24WarningsExact identifier
application number: M016
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3cf22c5a-f9a0-4bfb-e063-6394a90af8dd2025-08-22WarningsExact identifier
application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A DLANOLIN, PETROLATUMMY IMPORTS USA LLC3cf37fa7-6be4-b835-e063-6394a90ad4062025-08-22WarningsExact identifier
application number: M016
Awaken Moisturizing CreamDIMETHICONEGuangzhou Danting Bath&Body Care Industry Co. Ltd486c7f05-708a-44a1-8fc0-78344f5018db2025-08-21WarningsExact identifier
application number: M016
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTELEEO BRANDS LLC2992285b-bcdb-c0da-e063-6294a90ac6502025-08-19WarningsExact identifier
application number: M016
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
application number: M016
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
application number: M016
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10967-676-64109670676643.7 g in 1 TUBE (10967-676-64) 3.7 g2023-02-01NoNoCurrent