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 213 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	351251f5-e656-98b6-e063-6394a90ad805	2025-05-14	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	35129e6f-c6bd-a9f7-e063-6394a90ab0e4	2025-05-14	Warnings	Exact identifier application number: M020
Noevir Raysela UV Shield Primer	ZINC OXIDE, OCTINOXATE	Nippon Shikizai, Inc.	45030b2f-21cf-4285-af12-87ea8f0b8df7	2025-05-14	Warnings	Exact identifier application number: M020
OS-01 Lip SPF BS SPF15	ZINC OXIDE	ONESKIN INC.	351d55f6-fcd9-1d47-e063-6294a90a2cf0	2025-05-14	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350cd329-8fe2-314f-e063-6394a90ac954	2025-05-13	Warnings	Exact identifier application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30	ZINC OXIDE	Lancer Skincare LLC	522a9158-2fd1-4634-adef-2ba84c86bcd7	2025-05-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Navajo Manufacturing Company Inc.	33f13aa4-9279-c251-e063-6294a90a2d67	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	Allure Labs	34f51ff4-541d-2b2e-e063-6394a90a39da	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Natural SPF 30	ZINC OXIDE	Renu Laboratories, LLC	e7035fcd-6894-3360-e053-2a95a90a6f1d	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Sport SPF	ZINC SPF	RENU LABORATORIES, LLC	c9b48a9e-d69f-65a7-e053-2995a90a0baf	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	Allure Labs	34f674c1-5d59-915a-e063-6394a90a6c2f	2025-05-12	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE	Meaningful Beauty, LLC	f59fe019-569b-49ba-accf-fa4d356ce96b	2025-05-12	Warnings	Exact identifier application number: M020
Cicatricure Gold Lift SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Genomma Lab USA	34cc5b3c-af36-e202-e063-6294a90a13a7	2025-05-10	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b6aa46-657b-2676-e063-6294a90abadd	2025-05-09		Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a5a99f-9e22-52ab-e063-6294a90a9323	2025-05-08		Exact identifier application number: M020
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	08b7eeeb-09ae-ffe6-e063-6294a90aba90	2025-05-07	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE N	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	fe19a057-a3c6-4c53-92f9-a4a960cd5b08	2025-05-07	Warnings	Exact identifier application number: M020
Winter Survival Kit	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Duke Cannon Supply Co.	2487ab56-7856-66b0-e063-6394a90a9d87	2025-05-07	Warnings	Exact identifier application number: M020
OS-01 Lip SPF BS SPF15	ZINC OXIDE	Allure Labs	3490ed60-60b9-dfcd-e063-6394a90ab17a	2025-05-07	Warnings	Exact identifier application number: M020
Lip Love Moisture Balm SPF30 - Nude Beige	ZINC OXIDE	Koco Life LLC	3491084b-348a-f2bf-e063-6394a90abd25	2025-05-07	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