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 152 of 163 · 3,256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZERAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONECLINIQUE LABORATORIES LLC2e9463df-1c71-465f-9820-6cedefe07ad72023-10-20WarningsExact identifier
unii: 4Y5P7MUD51
CL EB MATTE MAKEUP BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC082b297e-d1d9-16b2-e063-6294a90a2ffd2023-10-20WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI062ffd88-2016-3c4d-e063-6394a90a5cf92023-10-20WarningsExact identifier
unii: 15FIX9V2JP
CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25TITANIUM DIOXIDE, ZINC OXIDECLINIQUE LABORATORIES LLC884abba1-891d-4c3c-b203-38a5a8a577562023-10-19WarningsExact identifier
unii: 15FIX9V2JP
Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALMRaining Roseefe25551-777c-5336-e053-2a95a90a5c232023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Mint Broad Spectrum SPF 15 Lip MoisturizerMINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf471721-54e4-0738-e053-2a95a90a7e122023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Spearmint SPF 15 Broad Spectrum Lip BalmSPEARMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9029e6d-7443-efe2-e053-2995a90a81252023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Watermelon Twist SPF 15 Broad Spectrum Lip BalmWATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0de5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Vanilla Mint SPF 15 Broad Spectrum Lip BalmVANILLA MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9031b15-d2b0-d248-e053-2a95a90a65ff2023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Cherry SPF 15 Broad Spectrum Lip BalmCHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a7326-aaa4-767b-e053-2995a90adf162023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Wildberry SPF 15 Broad Spectrum Lip BalmWILDBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903c855-867b-4f14-e053-2a95a90a53332023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Tropical SPF 15 Broad Spectrum Lip BalmTROPICAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903202b-1dc6-85ad-e053-2995a90a4ab82023-10-18WarningsExact identifier
unii: 4Y5P7MUD51
Pomegranate SPF 15 Broad Spectrum Lip BalmPOMEGRANATE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901e45d-2ea6-bae8-e053-2a95a90afc982023-10-18WarningsExact identifier
unii: 4Y5P7MUD51

Reported adverse events (FAERS/openFDA)#

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