FDA.reportPublic FDA data

NDC 67938-0105-2 - Eight Hour Cream Skin Protectant

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
67938-0105
Requested NDC
67938-0105-2
Package NDCs from labels
67938-0105-2, 67938-0105-1, 67938-0105-4, 67938-0105-3, 67938-0105-6, 67938-0105-5
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 Skin Protectant - Elizabeth Arden, IncElizabeth Arden, Inc2011-01-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-0105-12020-01-31C16284748780-19d75b9d0-5d64-f424-e053-dadaa90a57ceBC0105
67938-0105-32020-01-31C16284748780-19d75b9d0-5d64-f424-e053-dadaa90a57ceBC0105
67938-0105-52020-01-31C16284748780-19d75b9d0-5d64-f424-e053-dadaa90a57ceBC0105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-0105-1Eight Hour Cream Skin Protectant1 in 1 BOXLOTION15
67938-0105-2Eight Hour Cream Skin Protectant50 g in 1 TUBELOTION505
67938-0105-3Eight Hour Cream Skin Protectant1 in 1 BOXLOTION15
67938-0105-4Eight Hour Cream Skin Protectant15 g in 1 TUBELOTION155
67938-0105-5Eight Hour Cream Skin Protectant1 in 1 BOXLOTION15
67938-0105-6Eight Hour Cream Skin Protectant30 g in 1 TUBELOTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-0105EIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5Legacy NDC, 6 package rows20111006_a2647f00-eb2c-4be8-9c46-d100b0447e92.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
PETROLATUMACTIVE MOIETY4T6H12BN9UEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
CORN OILINACTIVE INGREDIENT8470G57WFMEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
LANOLININACTIVE INGREDIENT7EV65EAW6HEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZEIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]5

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 2 of 105 · 2,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPPEE WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.568a84eb-c0f7-6ce6-e063-6294a90a15b42026-09-08WarningsExact identifier
unii: O414PZ4LPZ
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5652eb70-23f2-91cb-e063-6294a90a11962026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Jorvinl WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.55c66a49-9d89-84a2-e063-6294a90a114e2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Youggle WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54e97ada-b3fa-0411-e063-6294a90a6ecd2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
OCSINL WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.54c206b9-758e-4baf-e063-6394a90afa992026-09-08WarningsExact identifier
unii: O414PZ4LPZ
DVO WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53e389a6-722c-dc65-e063-6294a90ac7dc2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Flyleaf WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.53f1ca40-e909-e9df-e063-6294a90a97912026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Leader Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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