No7 Soft and Sheer Tinted Moisturiser Medium

Product NDC: 61589-1905
11-digit product format: 615891905
Labeler code: 61589
Product ID: 61589-1905_4939ae99-6e9f-4b63-adc6-2bec3a92151b
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Titanium Dioxide
Dosage form: EMULSION
Route: TOPICAL
Labeler: BCM Cosmetique SAS
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-03-05
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 3 mL/50mL; mL/50mL
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	61589-1905		I	Inactivated by FDA		2026-10-12
excluded package	package	61589-1905	61589-1905-7	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 1 · 44 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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`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	61589-1905-7	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61589-1905-7	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61589-1905-7	`110d247fa046…`	`a55b01930146…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61589-1905-7	2019-10-29	C162847	48780-1	960f7f55-d30d-8e05-e053-dbdaa90a074a	Carton and tube labelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61589-1905-7	No7 Soft and Sheer Tinted Moisturiser Medium	1 in 1 CARTON	EMULSION	1		1
61589-1905-7	No7 Soft and Sheer Tinted Moisturiser Medium	50 mL in 1 TUBE	EMULSION	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
CYCLOMETHICONE 6	INACTIVE INGREDIENT	XHK3U310BA	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61589-1905	NO7 SOFT AND SHEER TINTED MOISTURISER MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [BCM COSMETIQUE SAS]	1	Legacy NDC, 2 package rows	20101207_00ef44c2-3acf-4d31-93b6-fa6e50699cd5.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	Status
61589-1905-7	61589190507	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carton and tube labelling	BCM Cosmetique SAS \| The Boots Company PLC	2010-12-06	HUMAN OTC DRUG LABEL	1