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 32 of 50 · 996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
unii: 95OOS7VE0Y
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
unii: 4T6H12BN9U
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
unii: 95OOS7VE0Y
Walgreens Scar Cream w/SPF 30AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%Walgreenscc72c8c5-f3e9-e8e0-e053-2a95a90ae0b02024-12-11WarningsExact identifier
unii: 95OOS7VE0Y

Reported adverse events (FAERS/openFDA)#

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