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 90 of 284 · 5,671 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766b0d8-20e6-a227-e063-6294a90af4da	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	374f866d-eb52-61e3-e063-6394a90a77c7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	3750c23d-c3f8-fac3-e063-6394a90a135e	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	KATHY JONES AESTHETHICS LLC	37dab729-5988-5eba-e063-6294a90ac6b7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tory Sullivan, M.D., P.A.	36241e60-f02a-50a7-e063-6394a90a6390	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e09a8-308b-b753-e063-6394a90ae9e5	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e2498-7df2-f22c-e063-6294a90ac6ab	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3bf5a6-33ec-0255-e063-6294a90ac96a	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3cba2e-acc6-a2df-e063-6294a90abf71	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3c757f-6581-4978-e063-6294a90a6173	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Virgo SOL Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d4f43-8c57-9fcf-e063-6294a90aa916	2025-12-16		Exact identifier unii: 15FIX9V2JP
Virgo SOL Non Tinted Mousse	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d63a9-b9ab-9530-e063-6394a90ac8ef	2025-12-16		Exact identifier unii: 15FIX9V2JP
Kind Restore Moisturizing Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	POLISH BEAUTY	39814e27-4f3f-5ee6-e063-6394a90a941b	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365da1f8-5250-7589-e063-6294a90a3e68	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Non Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365d7564-3025-257b-e063-6294a90ad170	2025-12-16		Exact identifier unii: 15FIX9V2JP
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier unii: 15FIX9V2JP
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILL VALLEY DERMATOLOGY, INC.	3b171a89-c757-47a1-e063-6294a90a7a64	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3793a-ccb5-1e5f-e063-6294a90ad44f	2025-12-16		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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