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 27 of 50 · 996 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunfrog Ultra SPF 30 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYOraLabs61299626-bf60-40e8-a2d3-4d4a99d8d15c2025-04-30WarningsExact identifier
unii: 95OOS7VE0Y
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
unii: 95OOS7VE0Y
unii: 4T6H12BN9U
OraLabs ChapIce Cherry PetrolatumPETROLATUMOraLabsf0d9d01e-bfdf-4e33-abfb-f683d414d8082025-04-29WarningsExact identifier
unii: 4T6H12BN9U
Tea Tree Lip Balm, SPF 15OCTINOXATE, OXYBENZONEOraLabsce11b043-0290-4c18-afbc-df4e49656c312025-04-28WarningsExact identifier
unii: 95OOS7VE0Y
SPF 45 - Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMOraLabsafd10abe-1e8b-4df8-9d8c-ef15266c510c2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
OraLabs SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMOraLabs3ac8569f-4b11-4536-8919-234f79bbd7fc2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
ChapIce SPF 30 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMOraLabsc7094485-a19f-41b7-88b8-d6d472adbff12025-04-22WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
unii: 4T6H12BN9U
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
unii: 95OOS7VE0Y
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: 4T6H12BN9U
St. Paul Brands VerestorVITAMIN C,VITAMIN E,NATTOKINASE,PHYTOSTEROL,DOKUDAMI LEAF,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals0e0b6c75-0ae8-4ef4-ab86-0f3be5ca63d12025-03-31WarningsExact identifier
unii: H4N855PNZ1
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
unii: 4T6H12BN9U
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
unii: 95OOS7VE0Y
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
unii: 95OOS7VE0Y
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
unii: 95OOS7VE0Y
Arthcal VULVA BALMBEESWAX,SHEA BUTTER,GRAPE SEEDBeijing JUNGE Technology Co., Ltd.2f305967-207b-6da9-e063-6294a90a571c2025-03-11WarningsExact identifier
unii: 2ZA36H0S2V
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
Winco Medicated Lip BalmPETROLATUMWincoc81cd9f7-f23a-4873-8542-1926497d39ce2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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