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 74 of 286 · 5,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
unii: 95OOS7VE0Y
unii: 5A68WGF6WM
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
unii: 5A68WGF6WM
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
unii: 5A68WGF6WM

Reported adverse events (FAERS/openFDA)#

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