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 269 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1ce728be-966e-b662-e063-6394a90a0ba82024-10-30WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENECOSMAX USA, INC.2596a17e-4042-3544-e063-6294a90aa4c92024-10-29WarningsExact identifier
application number: M020
SunbloczZINC OXIDEOlen Skin Care Corporation36fec1f1-5e8b-5764-e054-00144ff8d46c2024-10-29WarningsExact identifier
application number: M020
Sunblocz Baby and KidsZINC OXIDEOlen Skin Care Corporation35cbb9d5-639c-207a-e054-00144ff88e882024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.fd7d40fe-178a-e1b1-e053-6294a90a29a12024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTDe4a06973-21bb-4eda-9b74-fc23bee141ab2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD36efd48b-910e-4b61-9519-a6d5c7e9a7c32024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
application number: M020
SPF 15 Coconut Lip BalmZINC OXIDENaples Soap Company, Inc.25a7510f-5ef3-9920-e063-6394a90a20792024-10-29WarningsExact identifier
application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face ProtectionHOMOSALATE, OCTOCRYLENE, AVOBENZONEBel Star S.A. (Colombia)a7d69691-cecc-798e-e053-2a95a90a995f2024-10-28WarningsExact identifier
application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBel Star S.A.eea17271-e8c8-ab21-e053-2995a90a2fcc2024-10-28WarningsExact identifier
application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SAfd90ffc6-a1e1-e02e-e053-6294a90a4e7c2024-10-28WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.0b782198-58e7-5343-e063-6294a90a37132024-10-28WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENOwen Biosciences Incdabd3b95-01d3-014c-e053-2a95a90a0fec2024-10-28WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBAY BELLE LABS259653e7-dfe0-44a2-e063-6294a90a416d2024-10-28WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a21acbe-2f3d-cf78-e053-2a95a90a77f62024-10-27WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7961ff9f-75db-4977-e053-2a91aa0ae6282024-10-27WarningsExact identifier
application number: M020
Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a1c9a3c-394e-9122-e053-2995a90acb232024-10-27WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8b889b75-07ac-4276-e053-2a95a90a69c62024-10-27WarningsExact 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