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 16 of 192 · 3,834 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
unii: 4Y5P7MUD51
Sun Bum Amazon 8 OZ SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum522fc8a4-ce9f-8be8-e063-6294a90aebf02026-05-19WarningsExact identifier
unii: G63QQF2NOX
Hampton Sun SPF 50AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLC4df050f9-1185-4ee4-a0cd-84ba9d254e582026-05-18Exact identifier
unii: G63QQF2NOX
Hampton Sun SPF 70 KidsAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLC7c976082-3265-4c0b-9985-277d279888952026-05-18WarningsExact identifier
unii: G63QQF2NOX
cle de peau BEAUTE RESTORATIVE DAY SUPREMEAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporation157e52c5-f6fa-430b-bbb8-86b7c0868ad32026-05-18WarningsExact identifier
unii: G63QQF2NOX
cle de peau BEAUTE SKIN BEAUTY ENHANCERAVOBENZONE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationbc6230f1-dba2-4418-b48c-c5e67aebd1bd2026-05-18WarningsExact identifier
unii: G63QQF2NOX
Hampton Sun SPF 30 SILK BODYAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLCed0c184d-473a-4c4c-b6ec-e1d79ad584602026-05-18WarningsExact identifier
unii: G63QQF2NOX
Sheer Defense Tinted SPF 46ZINC OXIDE, OCTINOXATEPrivate Label Skin Care017265e9-31e6-43ce-9432-cb88f471c4962026-05-18WarningsExact identifier
unii: 4Y5P7MUD51
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC51d59378-df72-e438-e063-6294a90a97f12026-05-15WarningsExact identifier
unii: G63QQF2NOX
Natural Sense SPF 50 SunscreenSUNSCREENDr. Natural LLC49a2430e-c15b-4610-e063-6294a90ac5202026-05-15WarningsExact identifier
unii: G63QQF2NOX
unii: 4Y5P7MUD51
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 4Y5P7MUD51
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 4Y5P7MUD51
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51de3d0b-2721-92d3-e063-6394a90a18bb2026-05-15WarningsExact identifier
unii: G63QQF2NOX
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: 4T6H12BN9U
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
unii: 4T6H12BN9U
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: G63QQF2NOX
Hampton Sun SPF 8 Bronze SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLC7cf4d943-be6e-4e38-8891-1e0b22af55362026-05-14WarningsExact identifier
unii: G63QQF2NOX
SunPlus Healthy Skin Sunny Living SPF 30 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC9b168046-3536-4ba9-9b5f-4f8c50b8b3542026-05-14WarningsExact identifier
unii: G63QQF2NOX
SunPlus Healthy Skin Sunny Living SPF 50 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC0e60ecee-d9f4-47e0-92f7-ff319e4422dd2026-05-14WarningsExact identifier
unii: G63QQF2NOX
Hampton Sun SPF 15 SunscreenOCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%S&C Hampton Sun LLC3ce75e74-b5d3-4fbe-8d44-9b6f14f354df2026-05-14WarningsExact identifier
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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