NDC 67938-0774-2 - Eight Hour Cream Lip Protectant SPF 15

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
67938-0774
Requested NDC
67938-0774-2
Package NDCs from labels
67938-0774-2, 67938-0774-1
Manufacturer
Elizabeth Arden, Inc
Effective date
2011-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Eight Hour Cream Lip Protectant SPF 15 - Elizabeth Arden, IncElizabeth Arden, Inc2011-01-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-0774-12020-01-31C16284748780-19d75b9d0-208c-f424-e053-dadaa90a57ceBL0774

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-0774-1Eight Hour Cream Lip Protectant SPF 151 in 1 BOXSTICK13
67938-0774-2Eight Hour Cream Lip Protectant SPF 153.7 g in 1 TUBESTICK3.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-0774EIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3Legacy NDC, 2 package rows20110718_aeeb3768-e03d-43c8-9cd0-7e8a8508b207.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
PADIMATE OACTIVE INGREDIENTZ11006CMUZEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
PADIMATE OACTIVE MOIETYZ11006CMUZEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
PETROLATUMACTIVE MOIETY4T6H12BN9UEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19EIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
CORN OILINACTIVE INGREDIENT8470G57WFMEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
MYRISTYL LACTATEINACTIVE INGREDIENT1D822OC34XEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
OXYBENZONEINACTIVE INGREDIENT95OOS7VE0YEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VEIGHT HOUR CREAM LIP PROTECTANT SPF 15 (PETROLATUM) STICK [ELIZABETH ARDEN, INC]3

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 41 of 50 · 996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
unii: 4T6H12BN9U
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
unii: 4T6H12BN9U
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
unii: 4T6H12BN9U
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
unii: 4T6H12BN9U
Banana BoatAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands, LLC39a5a3be-f9a7-4fa1-e054-00144ff88e882024-02-23WarningsExact identifier
unii: 95OOS7VE0Y
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
unii: 95OOS7VE0Y
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
unii: 95OOS7VE0Y
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
unii: 95OOS7VE0Y
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
unii: 4T6H12BN9U
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
unii: 4T6H12BN9U
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONESafetec of America, Inc.754186c8-3c88-40a0-a4e3-35e3ea9d1b4c2024-02-08WarningsExact identifier
unii: 95OOS7VE0Y
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
unii: 4T6H12BN9U
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
unii: 4T6H12BN9U
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
unii: 4T6H12BN9U
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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