Compact Foundation SPF 50

Product NDC: 65371-051
11-digit product format: 653710051
Labeler code: 65371
Product ID: 65371-051_e7d6117a-8a96-43b4-8433-513f88704f0e
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, and Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: ORLANE, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-08-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength: 25 mg/mL; mg/mL; mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65371-051		D	Discontinued by firm		2026-10-12
excluded package	package	65371-051	65371-051-01	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65371-051-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65371-051-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65371-051-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65371-051-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65371-051-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65371-051-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65371-051-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65371-051-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65371-051-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65371-051-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65371-051-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65371-051-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65371-051-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65371-051-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65371-051-01	2020-07-23	C162847	48780-1	9d75b9d0-fd7b-f424-e053-dadaa90a57ce	Compact Foundation SPF 50 Color 01
65371-051-01	2020-01-31	C162847	48780-1	9d75b9d0-fd7b-f424-e053-dadaa90a57ce	Compact Foundation SPF 50 Color 01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
ISOSTEARYL NEOPENTANOATE	INACTIVE INGREDIENT	411THY156Q	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
POLY(METHYL METHACRYLATE; 450000 MW)	INACTIVE INGREDIENT	Z47NNT4J11	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
PPG-15 STEARYL ETHER	INACTIVE INGREDIENT	1II18XLS1L	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
SILICA DIMETHYL SILYLATE	INACTIVE INGREDIENT	EU2PSP0G0W	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	COMPACT FOUNDATION SPF 50 COLOR 01 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [ORLANE, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Compact Foundation SPF 50 Color 01	ORLANE, Inc. \| Orlane, Orleans	2015-09-08	HUMAN OTC DRUG LABEL	1

Compact Foundation SPF 50

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#