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: ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength: 4; 5; 5; 10; 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

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

Field, Values table
Field	Values
Unii	9YQ9DI1W42, 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, 15FIX9V2JP

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

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9YQ9DI1W42	ENSULIZOLE	27503-81-7	ENSULIZOLE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OCTOCRYLENE - Exelencia importers Corp. \| Biocosmetica Exel Argentina SRL	Exelencia importers Corp. \| Biocosmetica Exel Argentina SRL	2025-01-01	HUMAN OTC DRUG LABEL	1