FDA.reportPublic FDA data

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

Product NDC
67623-005
11-digit product format
676230005
Labeler code
67623
Product ID
67623-005_2aad5b97-e64c-c678-e063-6294a90aa8c6
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
Dosage form
CREAM
Route
TOPICAL
Labeler
Biocosmetica Exel Argentina SRL
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
OCTOCRYLENE; OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ENSULIZOLE
Active strength
10; 5; 5; 5; 4 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
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
OCTINOXATE5 g/100mL
TITANIUM DIOXIDE5 g/100mL
ENSULIZOLE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2aad5b97-e64b-c678-e063-6294a90aa8c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67623-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS1 in 1 CARTONCREAM11
67623-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS100 mL in 1 TUBECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67623-005EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [BIOCOSMETICA EXEL ARGENTINA SRL]1Current NDC, 2 package rows20250113_2aad5b97-e64b-c678-e063-6294a90aa8c6.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 180 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 IvoryZINC OXIDECosmetic Enterprises Ltd2748c351-0a7d-6913-e063-6394a90a6ef22025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 NudeZINC OXIDECosmetic Enterprises Ltd265bd73f-2509-90c6-e063-6294a90a2e192025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
KinesysOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc50adf1db-118f-4843-b356-e239931606732025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Ince0949325-7de1-4da4-82b6-8004916412a02025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free SunscreenOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc9adea1a4-efa6-4fe1-85e8-ed69fa098a872025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc60e7ed8e-f421-4e08-97a8-af647200e4ae2025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30ZINC OXIDEWilc Healthcare Ince5820376-897f-4c77-aadc-7991137870b72025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45ZINC OXIDEWilc Healthcare Inc247a323f-9a08-4717-8553-ebc9c519817b2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67623-005-01676230005011 TUBE in 1 CARTON (67623-005-01) / 100 mL in 1 TUBE1 tube2025-01-01NoNoCurrent