EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS

Product NDC: 53863-005
11-digit product format: 538630005
Labeler code: 53863
Product ID: 53863-005_2a845e4c-86e8-1799-e063-6294a90a9b2b
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: TITANIUM DIOXIDE; OCTOCRYLENE; OCTISALATE; ENSULIZOLE; OCTINOXATE
Active strength: 5; 10; 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 WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	5 g/100mL
OCTOCRYLENE	10 g/100mL
OCTISALATE	5 g/100mL
ENSULIZOLE	4 g/100mL
OCTINOXATE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
9YQ9DI1W42	Internal UNII lookup
4Y5P7MUD51	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
2a845e4c-86e7-1799-e063-6294a90a9b2b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53863-005-01	EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	100 mL in 1 TUBE	CREAM	100		1
53863-005-01	EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN 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
53863-005	EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [EXELENCIA IMPORTERS CORP.]	1	Current NDC, 2 package rows	20250113_2a845e4c-86e7-1799-e063-6294a90a9b2b.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 182 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Vertra Pearl White Face Stick SPF 50	PADIMATE O, TITANIUM DIOXIDE	Eai-jr 286, Inc	b69a75e0-8724-35ae-e053-2a95a90a5f34	2025-10-07	Warnings	Exact identifier application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige	TITANIUM DIOXIDE	EAI-JR 286, Inc.	b9ea12e8-6ed9-d805-e053-2a95a90aa107	2025-10-07	Warnings	Exact identifier application number: M020
SPF50 Sunscreen	SUNSCREEN	KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD	b3cde609-7d62-2ac7-e053-2a95a90a26b3	2025-10-07		Exact identifier application number: M020
Summer Face Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SUMMER GELEE LLC	fe256ff4-cb92-4262-8ab9-7cc912e0af22	2025-10-06	Warnings	Exact identifier application number: M020
Sun Veil Broad Spectrum SPF50	ZINC OXIDE	MONAT GLOBAL CORP	3ba28de7-74a2-5cde-e063-6394a90add26	2025-10-06	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53863-005-01	53863000501	1 TUBE in 1 CARTON (53863-005-01) / 100 mL in 1 TUBE	1 tube	2025-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TITANIUM DIOXIDE - Exelencia importers Corp. \| Biocosmetica Exel Argentina SRL	Exelencia importers Corp. \| Biocosmetica Exel Argentina SRL	2024-12-30	HUMAN OTC DRUG LABEL	1