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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
9YQ9DI1W42	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283c2780-5ad5-38f1-e063-6294a90ac336	Available on FDA.report

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 195 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum 50 Premium Moisturizing Sunscreen Roll-On	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c58c9c7-ca9e-d012-e063-6394a90a5aa9	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a003d82-90bd-f541-e063-6394a90ac906	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a00e4fb-6bf2-4c44-e063-6294a90a61bf	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a0f99df-e6c0-71d9-e063-6294a90a4c9e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	ZINC OXIDE	Sun Bum, LLC	3a13d4f1-c158-7fa0-e063-6294a90a6fb4	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen Face Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a147fe1-0dda-5433-e063-6394a90a1a59	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Sunscreen Browning	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c5b0db8-f05a-2b5c-e063-6294a90ae79b	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3aaf7d28-b306-b416-e063-6294a90a021e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a263b85-e7a0-c068-e063-6294a90a49f2	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen Roll-On	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a392237-019d-2384-e063-6394a90a5b24	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3a3b3b4a-148c-1dc5-e063-6394a90a7bdb	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac48eef-f651-af96-e063-6294a90a501e	2025-08-14	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	6a398dad-2fb9-4cdb-86c5-2a392b88f29b	2025-08-13	Warnings	Exact identifier application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40	ZINC OXIDE	ALL THE RAJE, LLC	9ffbd53b-1295-42b4-9cd5-18cbb75921d0	2025-08-13	Warnings	Exact identifier application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre	ZINC OXIDE	Power Beauty Co.	2e6eac42-0b70-44ea-e063-6294a90a49f8	2025-08-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE/OCTOCRYLENE/OXYBENZONE	Edgewell Personal Care Brands LLC	3c414e9b-6c3e-2c8d-e063-6394a90af4a6	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c443347-0134-8c87-e063-6294a90a8046	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3a22f0b9-2d6d-6230-e063-6294a90adf31	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c4567d6-879e-f995-e063-6394a90a319f	2025-08-13	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c457455-b9b1-546b-e063-6294a90a41f6	2025-08-13	Warnings	Exact identifier application number: M020

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

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

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