Exel Clarifying Line

Product NDC: 53863-125
11-digit product format: 538630125
Labeler code: 53863
Product ID: 53863-125_1c24bf21-f735-0247-e063-6394a90aec30
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octocrylene, Oxybenzone, Tatanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Exelencia importers
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-14
Substance: OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Active strength: 7.5; 8; 3; 5 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
Brand name suffix: SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	7.5 g/100mL
OCTOCRYLENE	8 g/100mL
OXYBENZONE	3 g/100mL
TITANIUM DIOXIDE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
95OOS7VE0Y	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
0d6d4098-4121-477e-b404-3ab18628ed68	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53863-125-02	2023-04-12	C162847	48780-1	f386c649-f075-0266-e053-dadaa90a7c1a	Exel Clarifying Line SPF 50
53863-125-02	2023-01-30	C162847	48780-1	f386c649-f075-0266-e053-dadaa90a7c1a	Exel Clarifying Line SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53863-125-01	Exel Clarifying LineSPF 50	100 mL in 1 TUBE	CREAM	100		8
53863-125-02	Exel Clarifying LineSPF 50	1 in 1 PACKAGE	CREAM	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	INACTIVE INGREDIENT	ANQ870JD20	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
ECTOINE	INACTIVE INGREDIENT	7GXZ3858RY	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
EDETATE CALCIUM DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8U5D034955	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
HAMAMELIS VIRGINIANA TOP	INACTIVE INGREDIENT	UDA30A2JJY	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2
YEAST, UNSPECIFIED	INACTIVE INGREDIENT	3NY3SM6B8U	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53863-125	EXEL CLARIFYING LINE SPF 50 (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	8	Current NDC, Legacy NDC, 2 package rows	20240708_0d6d4098-4121-477e-b404-3ab18628ed68.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 93 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08134b95-1879-27e5-e063-6294a90a29af	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	ded1f158-36d1-153f-e053-2995a90ace30	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08147940-0e8b-c894-e063-6394a90af8ac	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e468d703-fa6c-095a-e053-2a95a90a5194	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	0806bdb9-961f-3146-e063-6294a90a4625	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPL 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	df4b522e-93d4-1284-e053-2a95a90a1cd9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	088b7152-d3d1-9e74-e063-6394a90a4152	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a40ff-a014-3995-e063-6394a90a11e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	e451ecfb-cf17-c622-e053-2a95a90a4d4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	081484f8-58f5-f2a4-e063-6394a90a3379	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50	ZINC OXIDE (24.08%)	Beiersdorf Inc	09a97e3f-f6dc-eaa7-e063-6294a90ad274	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	f3e1ea21-4a07-3e18-e053-2995a90a0fe7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Sensitive Mineral Face Sunscreen SPF 35	ZINC OXIDE 24%	Beiersdorf Inc	f3a8bb6b-f051-5d39-e053-2a95a90adafc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	f41e09bf-407d-65a4-e053-2a95a90a2436	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Hydragel SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdort Inc	b5f7cacb-92b9-a6b7-e053-2a95a90aea02	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd6112fe-89e4-a79b-e053-2a95a90ad7f4	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Age Defense SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdort Inc	cd9d4f30-fb37-9935-e053-2995a90a9936	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	cc5d1f9b-2c8a-1392-e053-2a95a90acb9e	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23e368db-4b2f-d23b-e063-6394a90a1f06	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
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	Marketing end	Sample	Exclude flag	Status
53863-125-01	53863012501	100 mL in 1 TUBE	100 ml					Historical
53863-125-02	53863012502	1 TUBE in 1 PACKAGE (53863-125-02) / 100 mL in 1 TUBE (53863-125-01)	1 tube	2015-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exel Clarifying Line SPF 50	Exelencia importers \| Biocosmetica Exel Argentina SRL	2024-06-30	HUMAN OTC DRUG LABEL	8