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 17 of 289 · 5,763 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amber Sunglaze Sheer Body Mist Sunscreen SPF30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	5478fb36-e972-f824-e063-6294a90a567f	2026-06-17	Warnings	Exact identifier unii: 5A68WGF6WM
Humalog	INSULIN LISPRO	Eli Lilly and Company	c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f	2026-06-16	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	545aa56a-ed07-acd6-e063-6394a90ae0c7	2026-06-16	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
GlowBiotics Tinted Sunscreen SPF 30	ZINC OXIDE	Rum Brands, LLC	544dba29-4785-4ab6-e063-6394a90a17b3	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe Prime and Defend	ZINC OXIDE SUNSCREEN	Societe Clinical Skincare	5439bd31-5ee1-9bca-e063-6394a90a748c	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
Societe CoverShield Tinted SPF	ZINC OXIDE	Societe Clinical Skincare	545efbc4-82d4-f126-e063-6294a90a9710	2026-06-16	Warnings	Exact identifier unii: 15FIX9V2JP
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATE	Whole Foods Market, Inc.	82771f22-0197-40ba-97d2-2386152790ed	2026-06-15	Warnings	Exact identifier unii: 5A68WGF6WM
E-Z-GAS II	ANTACID/ANTIFLATULENT	E-Z-EM, INC.	4e12e1cb-b033-076d-e054-00144ff8d46c	2026-06-15	Warnings	Exact identifier unii: 92RU3N3Y1O
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Whole Foods Market, Inc.	1c31f466-6a0d-46ce-9346-d2a0eb46c8d0	2026-06-15	Warnings	Exact identifier unii: 5A68WGF6WM
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier unii: 15FIX9V2JP
Cellular Swiss UV Protection Veil SPF30	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	La Prairie, Inc.	dd946a3b-74b9-4ebd-b82f-0350f8f72834	2026-06-15	Warnings	Exact identifier unii: 5A68WGF6WM
Calamine, Pramoxind HCl	CALAMINE, PRAMOXIND HCL	H E B	4a7a0b09-d9bc-e752-e063-6394a90a9f2c	2026-06-15	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Calamine, Zinc Oxide	CALAMINE, ZINC OXIDE	H E B	4a79259e-64ac-d187-e063-6294a90a78db	2026-06-15	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Lifeline Medical, Inc	5438c185-31c9-c51e-e063-6394a90ae9ef	2026-06-14	Warnings	Exact identifier unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
BM BM70 DROPS	ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54113d1f-e8e7-6b4c-e063-6394a90a0edf	2026-06-12	Warnings	Exact identifier unii: 059QF0KO0R
Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	5411f284-f4ed-4e0e-e063-6294a90af1f6	2026-06-12	Warnings	Exact identifier unii: 5A68WGF6WM
Target Up and Up Oil Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	54141120-7682-9c05-e063-6394a90a877e	2026-06-12	Warnings	Exact identifier unii: 5A68WGF6WM
BM BM70 DROPS	ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB	BM Private Limited	53fa21d9-1f80-2e69-e063-6394a90ab9f3	2026-06-11	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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