FDA.reportPublic FDA data

NDC 67938-2016-2 - FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER

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
67938-2016
Requested NDC
67938-2016-2
Package NDCs from labels
67938-2016-2, 67938-2016-1
Manufacturer
Elizabeth Arden, Inc | Intercos
Effective date
2013-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OCTINOXATE and TITANIUM DIOXIDE - Elizabeth Arden, Inc | IntercosElizabeth Arden, Inc | Intercos2013-08-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2016-12020-01-31C16284748780-19d75b9d0-12e5-f424-e053-dadaa90a57ce250416

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2016-1FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER1 in 1 BOXLOTION11
67938-2016-2FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER1500 mg in 1 BOTTLELOTION15001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2016FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130814_9eb5e16f-1193-4d3e-8f95-d4c335a7a280.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
BETAINEINACTIVE INGREDIENT3SCV180C9WFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
MICAINACTIVE INGREDIENTV8A1AW0880FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RFLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [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 148 of 163 · 3,256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
unii: 4Y5P7MUD51
360 by QUR Spanish lime lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb3347-7498-3d7a-e053-2995a90a4b122023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
360 by QUR Watercress mint lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb7413-c074-a2d7-e053-2a95a90ac5cb2023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Grape Soda SPF 15 Broad Spectrum Lip BalmGRAPE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca09a0b5f-93e4-d18a-e053-2a95a90a65f72023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Broad Spectrum SPF 15 Sunscreen Unflavored Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALMRaining Roseefe20472-aa84-1cb4-e053-2a95a90abfd82023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Broad Spectrum SPF 15 Sunscreen Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALMRaining Roseefe1113b-6101-0c15-e053-2a95a90a02a72023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALMRaining Roseefe176f7-9c11-106e-e053-2a95a90a9c882023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Broad Spectrum SPF 15 Sunscreen Citrus Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALMRaining Roseefdfc182-3ac0-1a3d-e053-2a95a90a894e2023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALMRaining Roseefe01abd-0ee2-6bd6-e053-2a95a90a123d2023-10-26WarningsExact identifier
unii: 4Y5P7MUD51
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
unii: 4Y5P7MUD51
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact identifier
unii: 4Y5P7MUD51
Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.d5538bd0-4bab-4401-a0b8-632809a1e04c2023-10-25WarningsExact identifier
unii: 4Y5P7MUD51
Carmex Classic Lip Balm Medicated SPF 15OCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.ca20b2dc-97e5-461a-94c8-5c109cd152852023-10-25WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

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