NDC 53863-124-01 - Clarifying Line Broad Spectrum SPF 50 EXEL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 53863-124
Requested NDC: 53863-124-01
Package NDCs from labels: 53863-124-01, 53863-124-02
Manufacturer: Exelencia importers | Biocosmetica Exel Argentina SRL
Effective date: 2015-02-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OCTINOXATE - Exelencia importers \| Biocosmetica Exel Argentina SRL	Exelencia importers \| Biocosmetica Exel Argentina SRL	2015-02-23	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53863-124-02	2020-01-31	C162847	48780-1	9d75b9d0-2db5-f424-e053-dadaa90a57ce	Exel Clarifying Line SPF 50 Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53863-124-01	Clarifying Line Broad Spectrum SPF 50EXEL	100 mL in 1 TUBE	CREAM	100		1
53863-124-02	Clarifying Line Broad Spectrum SPF 50EXEL	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
53863-124	CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS]	1	Legacy NDC, 2 package rows	20150224_a13145c5-e7e1-434a-8b39-52c8b8ba8863.zip

DailyMed Socrata Ingredients#

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

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 12 of 289 · 5,763 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Remedy Barrier Cream Cloths Fragrance Free	DIMETHICONE	Medline Industries, LP	00e0cd4a-6049-408a-ab3f-9edf97e6438a	2026-07-14	Warnings	Exact identifier unii: 92RU3N3Y1O
X-Treme Cream Propolis Sunscreen SPF 45	X-TREME CREAM	Epicuren Discovery	3b29976e-eee0-b978-e063-6294a90accd6	2026-07-14	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
Anti-Aging Lip Balm SPF 15	LIP BALM	Epicuren Discovery	3cbd0550-b6e5-3e86-e063-6394a90ac07f	2026-07-14	Warnings	Exact identifier unii: 4Y5P7MUD51
FITISH SPF 50 FACE	FITISH SPF 50 FACE	Fitish Holdings, LLC	1c44a572-59e6-c3c5-e063-6394a90a0e24	2026-07-14	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
Vacation Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	14b8a3cf-031c-4c52-ba81-e683e69d0f37	2026-07-14	Warnings	Exact identifier unii: 5A68WGF6WM
Maximum Strength Antacid Mint	SIMETHICONE	Guardian Drug Company	48ec3132-17cf-1de9-e063-6294a90aa407	2026-07-14	Warnings	Exact identifier unii: 92RU3N3Y1O
Gas Relief	SIMETHICONE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	cce7f7db-99b8-4d7d-ac77-43da6323ebe1	2026-07-14	Warnings	Exact identifier unii: 92RU3N3Y1O
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	L. Perrigo Company	bd5c9df7-8dfb-4d20-9966-e148c5667b22	2026-07-14	Warnings	Exact identifier unii: 95OOS7VE0Y unii: 5A68WGF6WM
Olay Super Serum Body Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	5513c5e2-3baf-2f09-e063-6394a90a495a	2026-07-13	Warnings	Exact identifier unii: 5A68WGF6WM
PoutScreen Lip Treatment Lemon Meringue	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	563e3ab9-4ee2-279c-e063-6294a90a7cf1	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
Protect Sport Sunscreen	BROAD SPECTRUM SPF 30	Opal Day Spa	564704f2-b26a-d737-e063-6294a90aa6ff	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA, CORP	5648d637-9743-97a7-e063-6294a90ad8a1	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
COCO-EVE COCONUT MILK BODY SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564b80c2-16e0-fb5f-e063-6394a90a50d2	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	COSMAX USA	564b9b1f-3d5b-4349-e063-6294a90a3b77	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA	564bbb5f-4000-390d-e063-6294a90a408d	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
Gas Relief	SIMETHICONE	Rite Aid Corporation	43e94ffc-a3ec-4a16-98db-b000a6dc4230	2026-07-10	Warnings	Exact identifier unii: 92RU3N3Y1O
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb971e1-34f1-ee89-e063-6394a90a52a9	2026-07-09	Warnings	Exact identifier unii: 4Y5P7MUD51
Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 Sensitive	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	3cb9de81-f05e-9697-e063-6394a90a69c5	2026-07-09	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
Drs. DIAPER RASH MAXIMUM STRENGTH	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	161ba174-1b13-83cd-e063-6394a90af19c	2026-07-09	Warnings	Exact identifier unii: 92RU3N3Y1O
SOHEJU Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	560089ff-3361-90b7-e063-6294a90ada42	2026-07-09	Warnings	Exact identifier unii: ZY81Z83H0X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.