Exel Clarifying Line

Product NDC
53863-125
11-digit product format
538630125
Labeler code
53863
Product ID
53863-125_1c24bf21-f735-0247-e063-6394a90aec30
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Oxybenzone, Tatanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Exelencia importers
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-14
Substance
OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
7.5; 8; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Exel Clarifying Line
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OCTOCRYLENE8 g/100mL
OXYBENZONE3 g/100mL
TITANIUM DIOXIDE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d6d4098-4121-477e-b404-3ab18628ed68Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53863-125-022023-04-12C16284748780-1f386c649-f075-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50
53863-125-022023-01-30C16284748780-1f386c649-f075-0266-e053-dadaa90a7c1aExel Clarifying Line SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-125-01Exel Clarifying LineSPF 50100 mL in 1 TUBECREAM1008
53863-125-02Exel Clarifying LineSPF 501 in 1 PACKAGECREAM18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0REXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEINACTIVE INGREDIENTANQ870JD20EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
ECTOINEINACTIVE INGREDIENT7GXZ3858RYEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
SHEANUT OILINACTIVE INGREDIENTO88E196QRFEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
WATERINACTIVE INGREDIENT059QF0KO0REXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2
YEAST, UNSPECIFIEDINACTIVE INGREDIENT3NY3SM6B8UEXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-125EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]8Current NDC, Legacy NDC, 2 package rows20240708_0d6d4098-4121-477e-b404-3ab18628ed68.zip

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 86 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53863-125-0153863012501100 mL in 1 TUBE100 mlHistorical
53863-125-02538630125021 TUBE in 1 PACKAGE (53863-125-02) / 100 mL in 1 TUBE (53863-125-01) 1 tube2015-05-140000-00-00NoNoCurrent