Home NDC 53863-004 Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus
Product NDC 53863-004
11-digit product format 538630004
Labeler code 53863
Product ID 53863-004_283c2780-5ad6-38f1-e063-6294a90ac336
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 OCTOCRYLENE; OCTINOXATE; OCTISALATE; ENSULIZOLE; TITANIUM DIOXIDE
Active strength 10; 5; 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 white color Broad Spectrum SPF 60 plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 10 g/100mL OCTINOXATE 5 g/100mL OCTISALATE 5 g/100mL ENSULIZOLE 4 g/100mL TITANIUM DIOXIDE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53863-004-01 Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus 100 mL in 1 TUBE CREAM 100 1 53863-004-01 Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53863-004 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [EXELENCIA IMPORTERS CORP.] 1 Current NDC, 2 package rows 20250113_283c2780-5ad5-38f1-e063-6294a90ac336.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 133 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenishing Daily Protection ZINC OXIDE The Maui Medical Group, Inc 34b96d82-7fcf-e452-e063-6394a90a781b 2025-12-11 Exact identifier application number: M020 Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY LLC 3750c2fd-c5cc-fd00-e063-6394a90aeb89 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 3750ffbf-a82d-b4b9-e063-6294a90a7d68 2025-12-11 Exact identifier application number: M020 The Block ZINC OXIDE ELITE ESTHETICS BY NICOLE CAROLINE LLC 34a6b17e-6e9e-3f2c-e063-6294a90a1c32 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum Non-Tinted ZINC OXIDE Teton Dermatology Holdings, Inc. 35093797-008b-b265-e063-6294a90a9949 2025-12-11 Exact identifier application number: M020 Tinted Zinc Protection ZINC OXIDE Teton Dermatology Holdings, Inc. 3508d5a8-9d3c-51d1-e063-6394a90abc8e 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 35081ce0-2203-ab86-e063-6294a90aefd5 2025-12-11 Exact identifier application number: M020 Antioxidant SPF ZINC OXIDE Teton Dermatology Holdings, Inc. 3509a916-f3e1-9c53-e063-6394a90a5bff 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen Tinted ZINC OXIDE HALEM DERMATOLOGY PLLC 35bb4953-ca8c-e927-e063-6394a90a1a31 2025-12-11 Exact identifier application number: M020 Lip Protection TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 3509eea7-f966-2080-e063-6294a90aeeb5 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HALEM DERMATOLOGY PLLC 35bce44e-d9f4-9279-e063-6394a90a6453 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35bc5ff5-8eb8-54cf-e063-6394a90ae3c2 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350ad191-e51c-083d-e063-6394a90aa646 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35be5dc0-861f-3738-e063-6394a90a23ca 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350b2246-6e00-38fc-e063-6294a90ae382 2025-12-11 Exact identifier application number: M020 Calming Protection SPF40 ZINC OXIDE FRESH FACED SKIN CARE LLC 35d0c081-67b4-ce46-e063-6294a90ad822 2025-12-11 Exact identifier application number: M020 Tinted Facial Protection SPF40 TITANIUM DIOXIDE, ZINC OXIDE FRESH FACED SKIN CARE LLC 35d08e2a-b118-8634-e063-6294a90a918d 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE THE COMPLEXIONIST 38f53f6a-8e68-e30f-e063-6394a90afef2 2025-12-11 Exact identifier application number: M020 Fair Skin Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351bb329-90ea-f19a-e063-6394a90af107 2025-12-11 Exact identifier application number: M020 Oil Free Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351b4870-d9bd-c356-e063-6394a90a7763 2025-12-11 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53863-004-01 53863000401 1 TUBE in 1 CARTON (53863-004-01) / 100 mL in 1 TUBE 1 tube 2025-01-01 No No Current