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 76 of 190 · 3,786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5299f-6273-30ab-e063-6294a90a082e2025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
unii: 4Y5P7MUD51
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
unii: 7EV65EAW6H
unii: 4T6H12BN9U
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
unii: 4T6H12BN9U
By the Beach SuncareSPF 30 SUNCARE CITRUS CRUSHBy the Beach Suncare LLC43918d25-e947-5e17-e063-6394a90ada7c2025-11-14WarningsExact identifier
unii: G63QQF2NOX
By the Beach SuncareSPF 30 SUNCARE CANDY CLOUDSBy the Beach Suncare LLC4391728b-dfe8-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
unii: G63QQF2NOX
Naturium Dew-Glow Moisturizer SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5b80fb-caeb-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
unii: G63QQF2NOX
Naturium Dew Glow Tinted Moisturizer SPF50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d82f310-f87a-f76d-e063-6294a90af2512025-11-14WarningsExact identifier
unii: G63QQF2NOX
Naturium Dew Glow Tinted Moisturizer SPF50-deepHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d865e74-1baf-6a44-e063-6394a90a37ac2025-11-14WarningsExact identifier
unii: G63QQF2NOX
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d8616a8-2eab-c85c-e063-6294a90a39842025-11-14WarningsExact identifier
unii: G63QQF2NOX
Naturium UV Reflect Antioxidant SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c2025-11-14WarningsExact identifier
unii: G63QQF2NOX
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEONEAND CO., LTD.2dc41560-f4a7-5f0b-e063-6294a90a06302025-11-13WarningsExact identifier
unii: G63QQF2NOX
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
unii: 4T6H12BN9U
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
unii: 4T6H12BN9U
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
unii: G63QQF2NOX
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
unii: 4Y5P7MUD51
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)e3100877-6261-4502-8db8-d8ae3af6cd792025-11-12WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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