NDC 53863-124-01 - Clarifying Line Broad Spectrum SPF 50 EXEL

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
53863-124
Requested NDC
53863-124-01
Package NDCs from labels
53863-124-01, 53863-124-02
Manufacturer
Exelencia importers | Biocosmetica Exel Argentina SRL
Effective date
2015-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OCTINOXATE - Exelencia importers | Biocosmetica Exel Argentina SRLExelencia importers | Biocosmetica Exel Argentina SRL2015-02-23HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53863-124-022020-01-31C16284748780-19d75b9d0-2db5-f424-e053-dadaa90a57ceExel Clarifying Line SPF 50 Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-124-01Clarifying Line Broad Spectrum SPF 50EXEL100 mL in 1 TUBECREAM1001
53863-124-02Clarifying Line Broad Spectrum SPF 50EXEL1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-124CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1Legacy NDC, 2 package rows20150224_a13145c5-e7e1-434a-8b39-52c8b8ba8863.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEINACTIVE INGREDIENTANQ870JD20CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
ECTOINEINACTIVE INGREDIENT7GXZ3858RYCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ICLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
SHEANUT OILINACTIVE INGREDIENTO88E196QRFCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
WATERINACTIVE INGREDIENT059QF0KO0RCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]1
YEAST, UNSPECIFIEDINACTIVE INGREDIENT3NY3SM6B8UCLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]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 73 of 286 · 5,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
unii: 5A68WGF6WM
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Advanced Hydration Sunscreen SPF 30(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Inc1273012a-107c-1b19-e063-6394a90a53e42025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e5bf2c-88c2-d346-e063-6394a90abc782025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb728a-8c11-d041-e063-6294a90abb552025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Kids Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incc0421c97-72bd-fcac-e053-2995a90aac282025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
unii: 4Y5P7MUD51
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdort Incca8d2e20-c1f1-ecf2-e053-2a95a90a790f2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Tinted Age Defense Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc125d053c-9418-5772-e063-6294a90a6d6d2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport SPF 15 SunscreenAVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc4812da-0686-7789-e053-2995a90a561f2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
unii: 4Y5P7MUD51
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
unii: 5A68WGF6WM
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
unii: 5A68WGF6WM
unii: 4Y5P7MUD51
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
unii: 5A68WGF6WM

Reported adverse events (FAERS/openFDA)#

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