COVER FX TOTAL COVER FOUNDATION

Product NDC: 68327-010
11-digit product format: 683270010
Labeler code: 68327
Product ID: 68327-010_20b2c5ff-19eb-4427-9d33-38c18054d639
Type: HUMAN OTC DRUG
Nonproprietary name: OCTOCRYLENE, OCTISALATE, AVOBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: Cover FX Skin Care, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-10-01
Marketing end: 0000-00-00
Substance: OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength: 9 mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68327-010		I	Inactivated by FDA	2026-10-15
excluded package	package	68327-010	68327-010-01	I	Inactivated by FDA	2026-10-15
excluded package	package	68327-010	68327-010-03	I	Inactivated by FDA	2026-10-15

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-010-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-010-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-010-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-010-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-010-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-010-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-010-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-010-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-010-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-010-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-010-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-010-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-010-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-010-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-010-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-010-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-010-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-010-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-010-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-010-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-010-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-010-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-010-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-010-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-010-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-010-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-010-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-010-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-010-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-010-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68327-010-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68327-010-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68327-010-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68327-010-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68327-010-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68327-010-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68327-010-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68327-010-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68327-010-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68327-010-03	`e2bbac7714bc…`	`27bdfed8d636…`

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
68327-010-01	2020-01-31	C162847	48780-1	9d75b9d0-2afa-f424-e053-dadaa90a57ce	cd287df1-393a-477a-b23c-39ae08ac294a
68327-010-03	2020-01-31	C162847	48780-1	9d75b9d0-2afa-f424-e053-dadaa90a57ce	cd287df1-393a-477a-b23c-39ae08ac294a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68327-010-01	COVER FX TOTAL COVER FOUNDATIONSPF 30	10 g in 1 CASE	CREAM	10		5
68327-010-03	COVER FX TOTAL COVER FOUNDATIONSPF 30	1.5 g in 1 PACKET	CREAM	1.5		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
CERAMIDE 2	INACTIVE INGREDIENT	C04977SRJ5	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
CHROMIC OXIDE	INACTIVE INGREDIENT	X5Z09SU859	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
DIISOSTEARYL MALATE	INACTIVE INGREDIENT	QBS8A3XZGQ	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
ETHYL LINOLEATE	INACTIVE INGREDIENT	MJ2YTT4J8M	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
ETHYL LINOLENATE	INACTIVE INGREDIENT	T54Y8H042V	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
ETHYL OLEATE	INACTIVE INGREDIENT	Z2Z439864Y	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
HYDROGENATED POLYBUTENE (370 MW)	INACTIVE INGREDIENT	V5H8103878	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
NEOPENTYL GLYCOL DICAPRATE	INACTIVE INGREDIENT	77T908SE82	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
PEG-10 RAPESEED STEROL	INACTIVE INGREDIENT	258O76T85M	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT)	INACTIVE INGREDIENT	N0SS3Q238D	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68327-010	COVER FX TOTAL COVER FOUNDATION SPF 30 (OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [COVER FX SKIN CARE, INC.]	5	Legacy NDC, 2 package rows	20131028_cd287df1-393a-477a-b23c-39ae08ac294a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68327-010-01	68327001001	10 g in 1 CASE	10 g	Historical
68327-010-03	68327001003	1.5 g in 1 PACKET	1.5 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COVER FX TOTAL COVER FOUNDATION SPF 30 - Cover FX Skin Care, Inc.	Cover FX Skin Care, Inc.	2013-10-28	HUMAN OTC DRUG LABEL	5