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 201 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9efa5db5-d774-4089-895c-9667eda0f11b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L76232666-e23f-4842-bd0d-37819739ec3a2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L876b9a5d-dae3-47f1-9da6-b5e179fd28cd2025-08-06WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3bba29ab-0e08-b751-e063-6294a90adb7b2025-08-06WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTSTITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC3bba70e9-da29-f43b-e063-6294a90a08ef2025-08-06WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0127f290-8c5e-4285-e063-6294a90ae1282025-08-06WarningsExact identifier
application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe36550a6-a231-41a8-abda-afdbb2449eaa2025-08-06WarningsExact identifier
application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream PaletteOCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIcca417c8-b882-48a7-8bd8-ccc6f961a3d22025-08-06WarningsExact identifier
application number: M020
GR SATIN SMOOTHING Fluid Foundation SPF 15OCTINOXATE, OXYBENZONEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI1eba51f2-782e-480e-8555-f5ad8883fa0d2025-08-06WarningsExact identifier
application number: M020
GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI038ec45a-0d56-4cd9-8060-767b382c12372025-08-06WarningsExact identifier
application number: M020
GR CC Broad Spectrum SPF 30OCTINOXATE, OXYBENZONEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI751d5194-f5ea-401b-9439-7770510a588c2025-08-06WarningsExact identifier
application number: M020
GR NUDE LOOK SPF 25AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96dae912-8fa5-4d0e-b873-e1dbb7398db02025-08-06WarningsExact identifier
application number: M020
GR BB SPF 25OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI3b22579b-21ce-4b96-bd24-774ce35bf6f72025-08-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Invisible Gel Face Sunscreen SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3b9a4bd9-cbe1-60c5-e063-6394a90a58922025-08-05WarningsExact identifier
application number: M020
Neutrogena Hydro Boost City Shield water Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC77e4bbcc-0a51-4e9c-9328-46bcbf4f81292025-08-05WarningsExact identifier
application number: M020
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdecb4842-c880-0668-e053-2995a90aad7e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 08W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L498bf941-67f2-41d5-a039-9f827b68297e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 10N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L54e390bd-b84a-4c43-986e-74923e34689d2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 09C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L897024cd-576e-4a8e-8daa-92dc3bb4b3a52025-08-05WarningsExact 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