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 229 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quick Screen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Quick Flick PTY LTD3788666e-7efa-43da-95f5-6218b7fcb6ea2025-02-12WarningsExact identifier
application number: M020
Dolce AND Gabbana Get Your Healthy Glowy SkinZINC OXIDESocoplan91bf1cca-8d18-4c59-864d-4fd0619c67132025-02-12WarningsExact identifier
application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dfd1f99-5896-1e0f-e063-6394a90aa71d2025-02-12WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf9024581-dbab-b7cb-e053-6294a90a8b9a2025-02-12WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLCebdaf6c1-1572-4840-851b-6d780471fcb22025-02-11WarningsExact identifier
application number: M020
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
application number: M020
Beeswax SPF 15 Broad Spectrum Lip BalmBEESWAX SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc2dcc2f9b-4a8c-b281-e063-6294a90ad9d62025-02-10WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc2dcca380-c0e4-4e04-e063-6394a90ac31e2025-02-10WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2dd5ea23-eee6-5d14-e063-6294a90a0fd32025-02-10WarningsExact identifier
application number: M020
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc25afb-a171-f1f2-e063-6294a90ae3332025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc285ad-08cd-14e6-e063-6294a90a24fc2025-02-09WarningsExact identifier
application number: M020
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
application number: M020
NIA 24 SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENENiadyne Ince5c9d56f-48b4-4f0e-add6-f73268755b162025-02-07WarningsExact identifier
application number: M020
Pacific Mango Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANYd09e3096-0678-4433-a555-61f18a45873b2025-02-06WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact 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