Tinted BB

Product NDC: 67510-0378
11-digit product format: 675100378
Labeler code: 67510
Product ID: 67510-0378_615e314b-120f-4a88-e053-2a91aa0a8cb4
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Titanium dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Kareway Product, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-10-11
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 6 mg/100mg; mg/100mg
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	67510-0378		I	Inactivated by FDA	2026-10-12
excluded package	package	67510-0378	67510-0378-1	I	Inactivated by FDA	2026-10-12
excluded package	package	67510-0378	67510-0378-3	I	Inactivated by FDA	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 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	67510-0378-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67510-0378-1	`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	67510-0378-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67510-0378-1	`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	67510-0378-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67510-0378-1	`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	67510-0378-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67510-0378-1	`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	67510-0378-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67510-0378-1	`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	67510-0378-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67510-0378-1	`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	67510-0378-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0378-1	`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	67510-0378-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0378-1	`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	67510-0378-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0378-1	`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	67510-0378-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0378-1	`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	67510-0378-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0378-1	`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	67510-0378-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0378-1	`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	67510-0378-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67510-0378-1	`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	67510-0378-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67510-0378-1	`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	67510-0378-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67510-0378-1	`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	67510-0378-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67510-0378-1	`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	67510-0378-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67510-0378-1	`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	67510-0378-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67510-0378-1	`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	67510-0378-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67510-0378-1	`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	67510-0378-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67510-0378-1	`e2bbac7714bc…`	`27bdfed8d636…`

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
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0378-1	2020-01-31	C162847	48780-1	9d75b9d0-c790-f424-e053-dadaa90a57ce	Drug Facts
67510-0378-3	2020-01-31	C162847	48780-1	9d75b9d0-c790-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0378-1	Tinted BB	30 mg in 1 TUBE	CREAM	30		2
67510-0378-3	Tinted BB	40 mg in 1 TUBE	CREAM	40		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
BETAINE	INACTIVE INGREDIENT	3SCV180C9W	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
CETYL ETHYLHEXANOATE	INACTIVE INGREDIENT	134647WMX4	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
DISODIUM EDTA-COPPER	INACTIVE INGREDIENT	6V475AX06U	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0378	TINTED BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [KAREWAY PRODUCT, INC.]	2	Legacy NDC, 2 package rows	20171228_0de018dd-549c-4fbd-a5c9-3fbda53e527a.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67510-0378-1	67510037801	30 mg in 1 TUBE	30 mg	Historical
67510-0378-3	67510037803	40 mg in 1 TUBE	40 mg	Historical