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 94 of 284 · 5,671 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sun Protectant	TITANIUM DIOXIDE, ZINC OXIDE	PANDA PAMPERING LLC	387be96f-8cda-ce02-e063-6394a90abea5	2025-12-15		Exact identifier unii: 15FIX9V2JP
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37ede476-43b6-a7c8-e063-6294a90a3e8f	2025-12-15		Exact identifier unii: 15FIX9V2JP
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37efa5e1-e88e-d251-e063-6394a90a9371	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd330bf-92e4-3664-e063-6294a90a0475	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd37dd1-fd43-7af4-e063-6394a90ae3a0	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd3dcab-e9fb-0ef5-e063-6394a90acef1	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd40a6a-d52e-ab87-e063-6294a90a966e	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mattifying Skin Primer	TITANIUM DIOXIDE, ZINC OXIDE	SKIN MAVEN	37662032-2842-1982-e063-6294a90a49a0	2025-12-15		Exact identifier unii: 15FIX9V2JP
Deluxe Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	37657895-5fec-82d0-e063-6294a90acf67	2025-12-15		Exact identifier unii: 15FIX9V2JP
Facial Mineral Fusion	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35944621-e6fb-cd98-e063-6294a90aa641	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Mousse	TITANIUM DIOXIDE, ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d00778-3857-ce8f-e063-6394a90ab375	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	35933039-8beb-9f98-e063-6394a90a60bb	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	3592edca-cab0-6c44-e063-6294a90a1727	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38046e71-f171-7e96-e063-6294a90a1f0b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Barrier Plus Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38038beb-d0f0-ced2-e063-6294a90ac423	2025-12-15		Exact identifier unii: 15FIX9V2JP
Happy Mineral Sunscreen Primer SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE CLINIC LAS VEGAS BY JUSTINA	37d9c5f2-f414-6efa-e063-6294a90a927f	2025-12-15		Exact identifier unii: 15FIX9V2JP
Comfort Mineral Mousse Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	3765dd17-ffbd-bcf4-e063-6394a90a2c2b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Prime And Protect Matte	TITANIUM DIOXIDE, ZINC OXIDE	Kalon Skin Studio, LLC	35939630-1166-1c70-e063-6294a90aac6b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Goldberg, Howard S MD Inc	3598205d-2e87-9292-e063-6294a90a1f2a	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Formula Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3981c878-826d-f685-e063-6294a90acb24	2025-12-15		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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