FDA.reportPublic FDA data

EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS

Product NDC
53863-005
11-digit product format
538630005
Labeler code
53863
Product ID
53863-005_2a845e4c-86e8-1799-e063-6294a90a9b2b
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
Dosage form
CREAM
Route
TOPICAL
Labeler
Exelencia importers Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
TITANIUM DIOXIDE; OCTOCRYLENE; OCTISALATE; ENSULIZOLE; OCTINOXATE
Active strength
5; 10; 5; 4; 5 g/100mL; 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 DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE5 g/100mL
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
ENSULIZOLE4 g/100mL
OCTINOXATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a845e4c-86e7-1799-e063-6294a90a9b2bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS100 mL in 1 TUBECREAM1001
53863-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-005EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [EXELENCIA IMPORTERS CORP.]1Current NDC, 2 package rows20250113_2a845e4c-86e7-1799-e063-6294a90a9b2b.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 115 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f68b2ea-be23-100d-e063-6294a90a8b372025-12-16WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f682b78-e1c9-e174-e063-6294a90a17ed2025-12-16WarningsExact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3793a-ccb5-1e5f-e063-6294a90ad44f2025-12-16Exact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3a721-6be1-3f7f-e063-6394a90a522f2025-12-16Exact identifier
application number: M020
True Tone TintedTITANIUM DIOXIDE, ZINC OXIDEThat Face PLLC36c2bb0e-479d-89cd-e063-6294a90aa3d42025-12-16Exact identifier
application number: M020
True Tone Non TintedZINC OXIDEThat Face PLLC36c2f263-67cf-e8cf-e063-6394a90ad81f2025-12-16Exact identifier
application number: M020
Tinted Daily Protection SunscreenZINC OXIDEKemmi Lee Skin Science37ef5a05-54d2-a8e4-e063-6394a90a8e482025-12-16Exact identifier
application number: M020
Aquaphor Lip Repair Stick and SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Incd469bddf-90d4-7b1c-e053-2a95a90a1ed92025-12-16WarningsExact identifier
application number: M020
Eucerin Daily Protection FaceENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEBeiersdorf Inc76403f03-aee9-4c0b-b331-f79b6953118c2025-12-16WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
application number: M020
Eucerin Radiant ToneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc2611e0cb-d56d-6ea1-e063-6294a90a745b2025-12-16WarningsExact identifier
application number: M020
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEKLOE SALON LLC36c23c07-2011-3ddb-e063-6294a90a76e92025-12-16Exact identifier
application number: M020
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53863-005-01538630005011 TUBE in 1 CARTON (53863-005-01) / 100 mL in 1 TUBE1 tube2025-01-01NoNoCurrent