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 265 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISSHA ALL AROUND VITA C SUNSCREENZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDEAble C&C Co., Ltd.1a7ec673-328a-8924-e063-6294a90a2f3d2024-12-05WarningsExact identifier
application number: M020
(Re)Setting Refreshing Mist SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd4d8f28d-cb00-298d-e053-2995a90a10eb2024-12-05WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc2ba71f81-54d0-4955-9bae-2b6e35c9c35f2024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Body SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.db5f6bad-65ae-2b05-e053-2a95a90a85692024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Face SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.d91bba06-fd9b-3eb5-e053-2995a90a61242024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc65de9491-8804-4e3b-90a7-9b253e34b7d32024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc499e5352-fcc4-4434-96f2-4375816991c92024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Sheen Sunstick SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECay Skin, Inc.288c3aeb-01b2-ce39-e063-6394a90ad04a2024-12-05WarningsExact identifier
application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30ZINC OXIDECay Skin, Inc.288d5456-98f3-a998-e063-6294a90a83662024-12-05WarningsExact identifier
application number: M020
Solar Moisturizer SPF 30OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENEAllure Labs, LLCef4d54bf-25f5-4261-9d3d-c42b0d8922752024-12-05WarningsExact identifier
application number: M020
Clear Clear Zinc Solar Protection SPF 30ZINC OXIDEAllure Labs, LLC79a3c8e2-c4f2-4c00-8e94-494654ae91a22024-12-05WarningsExact identifier
application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEAramis Inc.8b206b6d-92e4-48bc-a40c-93ffdd6355352024-12-05WarningsExact identifier
application number: M020
Kids Broad Spectrum SPF 35ZINC OXIDEAllure Labs, LLCb72caf9b-46df-f30c-e053-2995a90a9b6d2024-12-05WarningsExact identifier
application number: M020
CBD Blue Light Defense SPF 30ZINC OXIDEAllure Labsb63b99af-2ddb-3535-e053-2a95a90a65d52024-12-05WarningsExact identifier
application number: M020
AHAVA CC SPF 30AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd2fa6249a-9614-455c-8e07-9b829f3b0c222024-12-04WarningsExact identifier
application number: M020
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact 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