FDA.reportPublic FDA data

NDC 67938-1111-2 - Eight Hour Cream Nourishing Lip Balm SPF 20

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67938-1111
Requested NDC
67938-1111-2
Package NDCs from labels
67938-1111-2, 67938-1111-1
Manufacturer
Elizabeth Arden, Inc
Effective date
2013-05-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Eight Hour Cream Nourishing Lip Balm SPF 20 - Elizabeth Arden, IncElizabeth Arden, Inc2013-05-02HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-1111-12020-01-31C16284748780-19d75b9d0-2f6b-f424-e053-dadaa90a57ce197107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-1111-1Eight Hour Cream Nourishing Lip Balm SPF 201 in 1 BOXSALVE11
67938-1111-2Eight Hour Cream Nourishing Lip Balm SPF 2014.2 g in 1 TUBESALVE14.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-1111EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130502_a6271ee2-39c2-445a-bb24-f87745ac69be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
ASTROCARYUM MURUMURU SEED BUTTERINACTIVE INGREDIENT12V64UPU6REIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
DIOCTYLDODECYL DODECANEDIOATEINACTIVE INGREDIENT7QDB5EE79YEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N14EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H71EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
NYLON-12INACTIVE INGREDIENT446U8J075BEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]1

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 6 of 192 · 3,834 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
unii: G63QQF2NOX
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
unii: G63QQF2NOX
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
unii: G63QQF2NOX
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
unii: 4T6H12BN9U
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
unii: 4T6H12BN9U
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
unii: 4T6H12BN9U
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
unii: 4T6H12BN9U
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAMBI Enterprises LLC99bbe9a2-bb57-4a33-b339-1649d4b319c82026-07-31WarningsExact identifier
unii: G63QQF2NOX
AMBI Even and Clear Facial Moisturizer SPF-30AVOBENZONE, OCTISALATE, OCTOCRYLENEAMBI Enterprises LLC4701c0ba-4ceb-4d66-9f99-515ce33b46482026-07-31WarningsExact identifier
unii: G63QQF2NOX
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
unii: G63QQF2NOX
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
unii: 4T6H12BN9U
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
unii: 4T6H12BN9U
HEB 50 Pumpkin Spice Latte Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.579f3274-398e-7eab-e063-6394a90afe352026-07-27WarningsExact identifier
unii: G63QQF2NOX
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.