FDA.reportPublic FDA data

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 22 of 289 · 5,763 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cle de peau BEAUTE RESTORATIVE DAY SUPREMEAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporation157e52c5-f6fa-430b-bbb8-86b7c0868ad32026-05-18WarningsExact identifier
unii: 5A68WGF6WM
cle de peau BEAUTE SKIN BEAUTY ENHANCERAVOBENZONE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationbc6230f1-dba2-4418-b48c-c5e67aebd1bd2026-05-18WarningsExact identifier
unii: 5A68WGF6WM
Hampton Sun SPF 30 SILK BODYAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLCed0c184d-473a-4c4c-b6ec-e1d79ad584602026-05-18WarningsExact identifier
unii: 5A68WGF6WM
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: 92RU3N3Y1O
Sheer Defense Tinted SPF 46ZINC OXIDE, OCTINOXATEPrivate Label Skin Care017265e9-31e6-43ce-9432-cb88f471c4962026-05-18WarningsExact identifier
unii: 4Y5P7MUD51
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC51d59378-df72-e438-e063-6294a90a97f12026-05-15WarningsExact identifier
unii: 5A68WGF6WM
Natural Sense SPF 50 SunscreenSUNSCREENDr. Natural LLC49a2430e-c15b-4610-e063-6294a90ac5202026-05-15WarningsExact identifier
unii: 5A68WGF6WM
unii: 4Y5P7MUD51
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 15FIX9V2JP
unii: 4Y5P7MUD51
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51de3d0b-2721-92d3-e063-6394a90a18bb2026-05-15WarningsExact identifier
unii: 5A68WGF6WM
gas reliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI2a82a06d-7511-4fc0-b182-9c1774b2af482026-05-15WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: 5A68WGF6WM
unii: 15FIX9V2JP
SunPlus Healthy Skin Sunny Living SPF 30 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC9b168046-3536-4ba9-9b5f-4f8c50b8b3542026-05-14WarningsExact identifier
unii: 5A68WGF6WM
SunPlus Healthy Skin Sunny Living SPF 50 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC0e60ecee-d9f4-47e0-92f7-ff319e4422dd2026-05-14WarningsExact identifier
unii: 5A68WGF6WM
Hampton Sun SPF 15 SunscreenOCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%S&C Hampton Sun LLC3ce75e74-b5d3-4fbe-8d44-9b6f14f354df2026-05-14WarningsExact identifier
unii: 5A68WGF6WM
Target Up and Up SPF 30 Deep Repair Facial Moisturizer SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51c9bdee-dcff-2818-e063-6294a90abb472026-05-14WarningsExact identifier
unii: 5A68WGF6WM
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIE29c9d1cb-e249-47fa-a46d-42190e59d3522026-05-14WarningsExact identifier
unii: 5A68WGF6WM
Hampton Sun SPF 4OCTOCRYLENE 4.00% AVOBENZONE 2.00%S&C Hampton Sun LLC68763abc-0d6b-441c-9a99-cf3dc86e6deb2026-05-14WarningsExact identifier
unii: 5A68WGF6WM

Reported adverse events (FAERS/openFDA)#

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