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 181 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Petroleum-Free Lip Balm OCTINOXATE AND OXYBENZONE Medline Industries, LP 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 1) ZINC OXIDE Resette, Inc dc89429a-022c-dd10-e053-2a95a90ac26a 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 2) ZINC OXIDE Resette, Inc dc89ab76-da2f-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Clear Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Spa de Soleil 40c11b19-fc91-2033-e063-6394a90a5a5f 2025-10-09 Warnings Exact identifier application number: M020 Black Girl Sunscreen Make It Mineral Baby ZINC OXIDE Black Girl Sunscreen 302bccc6-7bf3-cc69-e063-6294a90a625c 2025-10-09 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 CoreTex Professional Outdoor Skin Protection Wallet CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET CoreTex Products Inc f57bc089-405b-cdcd-e053-2995a90a9d12 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020 Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 29817fdc-f14c-4013-a8ed-4367f3b2867c 2025-10-09 Warnings Exact identifier application number: M020 Skinny Dip SPF-50 ZINC OXIDE Cove Suncare LLC 7bef2966-9351-4ea6-aeed-0d568376d86b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0ba2e9-126f-13c0-e063-6394a90aa6a4 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 08997bd4-d6b9-fffc-e063-6294a90a77ae 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Kenvue Brands LLC 75f81b2d-cabc-443f-b4b5-76bd2321826b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 1390f863-709e-412b-9a25-b65217844e44 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC ccc2e40b-5301-4055-8a89-47366687cfb7 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0dd2e4-3dda-c872-e063-6294a90a20a3 2025-10-08 Warnings Exact identifier application number: M020 ScalpHair MistSunscreen SPF30 COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30 COOLA LLC c7d2098f-6fdf-68e5-e053-2a95a90a1898 2025-10-08 Warnings Exact identifier application number: M020 Block Party SPF-50 ZINC OXIDE Cove Suncare LLC 24ffb6ec-d922-40c0-b325-c15f8433027a 2025-10-08 Warnings Exact identifier application number: M020 Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 40945805-6f2e-74a1-e063-6394a90a04a3 2025-10-07 Warnings Exact identifier application number: M020 ProtecTINT 10N HOMOSALATE, OCTISALATE, ZINC OXIDE Supergoop, LLC 0801287f-0df5-4303-e063-6394a90a503b 2025-10-07 Warnings 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