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 75 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cc0f19fc-7b6f-4454-9a77-dc11f0fd1251	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c361a514-5fc9-42a7-b1fc-28e4a11ad733	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	db38ced5-dfbe-4b7e-b4ae-3065df1898b0	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ead1ce8-f31d-4676-8619-8d49dd62db2e	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	827caf09-222e-487a-941c-44eb5c13d5d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f3c378e1-853b-463e-9fc3-6a54ef861044	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3a479c4-807e-4c52-a27f-eea8705b9c1e	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cb63faaa-82d8-469a-a9a1-88b09e02cc35	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c20b0b8b-366a-47ff-84b6-264fa8ed6de0	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31d89246-418d-4ed4-8e32-7aa2422073a9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31b74e11-c5e5-4086-baa5-e7a39dc556a0	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	29ec217b-7726-4590-8a0d-e4b08217e222	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ceabea37-020c-49e0-a049-3100ed46ff57	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	915a0b1f-b26e-4fea-95f3-ccec2bcab389	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9a313d8e-003d-4d40-b892-0f2270e4f6c2	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f560de93-4099-4ad9-8eb6-fe2a52ac82a1	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	824c5f13-970e-4e9e-8f2a-2a01973d2e59	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7621ef5-47fc-4ccc-aedd-eac328ace7b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64a29ff8-e24d-4818-9b54-734a0eb2a13f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17a0201b-b797-4e65-838f-1ce8d408a020	2026-01-16	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