BritePrep FX

Product NDC: 68327-005
11-digit product format: 683270005
Labeler code: 68327
Product ID: 68327-005_048bb7e5-b132-4b36-8274-8c8db1c1fb07
Type: HUMAN OTC DRUG
Nonproprietary name: OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Cover FX Skin Care, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-07-01
Marketing end: 0000-00-00
Substance: OCTOCRYLENE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength: 9 g/100mL; g/100mL; g/100mL; g/100mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68327-005		I	Inactivated by FDA	2026-10-15
excluded package	package	68327-005	68327-005-01	I	Inactivated by FDA	2026-10-15
excluded package	package	68327-005	68327-005-02	I	Inactivated by FDA	2026-10-15
excluded package	package	68327-005	68327-005-03	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 · 84 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	68327-005-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-005-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68327-005-01	`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	68327-005-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-005-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68327-005-01	`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	68327-005-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-005-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68327-005-01	`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	68327-005-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-005-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68327-005-01	`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	68327-005-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-005-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68327-005-01	`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	68327-005-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-005-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68327-005-01	`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	68327-005-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-005-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68327-005-01	`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	68327-005-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-005-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68327-005-01	`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	68327-005-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-005-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68327-005-01	`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	68327-005-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-005-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68327-005-01	`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	68327-005-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-005-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68327-005-01	`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	68327-005-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-005-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68327-005-01	`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	68327-005-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-005-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68327-005-01	`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	68327-005-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-005-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68327-005-01	`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	68327-005-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-005-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68327-005-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68327-005-01	2020-01-31	C162847	48780-1	9d75b9d1-0bd3-f424-e053-dadaa90a57ce	df0af55f-f2af-4786-bbb3-5bc59570b3f2
68327-005-02	2020-01-31	C162847	48780-1	9d75b9d1-0bd3-f424-e053-dadaa90a57ce	df0af55f-f2af-4786-bbb3-5bc59570b3f2
68327-005-03	2020-01-31	C162847	48780-1	9d75b9d1-0bd3-f424-e053-dadaa90a57ce	df0af55f-f2af-4786-bbb3-5bc59570b3f2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68327-005-01	BritePrep FX	30 mL in 1 TUBE	CREAM	30	1
68327-005-02	BritePrep FX	15 mL in 1 TUBE	CREAM	15	1
68327-005-03	BritePrep FX	5 mL in 1 TUBE	CREAM	5	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ARCTOSTAPHYLOS UVA-URSI LEAF	INACTIVE INGREDIENT	3M5V3D1X36	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ASCORBYL GLUCOSIDE	INACTIVE INGREDIENT	2V52R0NHXW	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
BRINE SHRIMP	INACTIVE INGREDIENT	3ID50N77DH	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3.7)	INACTIVE INGREDIENT	8INO2K35FA	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
CITRUS AURANTIUM FLOWER OIL	INACTIVE INGREDIENT	D4BGE91OXH	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER	INACTIVE INGREDIENT	RSA9I561OK	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	INACTIVE INGREDIENT	9E4CO0W6C5	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
GLYCERYL 1,2-DIBEHENATE	INACTIVE INGREDIENT	21E45121YS	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
HYDROGENATED POLYBUTENE (1300 MW)	INACTIVE INGREDIENT	7D1YQ9Y5EZ	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
ISOPROPYL TITANIUM TRIISOSTEARATE	INACTIVE INGREDIENT	949E3KBJ1I	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
LINOLENIC ACID	INACTIVE INGREDIENT	0RBV727H71	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
OCTADECENEDIOIC ACID	INACTIVE INGREDIENT	565ZMT5QRG	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
PALMITOYL TETRAPEPTIDE-7	INACTIVE INGREDIENT	Q41S464P1R	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TEA LEAF	INACTIVE INGREDIENT	GH42T47V24	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TEPRENONE	INACTIVE INGREDIENT	S8S8451A4O	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68327-005	BRITEPREP FX (OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE ) CREAM [COVER FX SKIN CARE, INC.]	1	Legacy NDC, 3 package rows	20130219_df0af55f-f2af-4786-bbb3-5bc59570b3f2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
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	Status
68327-005-01	68327000501	30 mL in 1 TUBE	30 ml	Historical
68327-005-02	68327000502	15 mL in 1 TUBE	15 ml	Historical
68327-005-03	68327000503	5 mL in 1 TUBE	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BritePrep FX - Cover FX Skin Care, Inc.	Cover FX Skin Care, Inc.	2013-02-19	HUMAN OTC DRUG LABEL	1