Sei Bella Skin Refining Tinted Moisturizer

Product NDC: 54473-250
11-digit product format: 544730250
Labeler code: 54473
Product ID: 54473-250_9aa1c49f-bbfc-4652-859c-0d82f43afb45
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Melaleuca Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-06-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE
Active strength: 3 g/44.4mL
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	54473-250		I	Inactivated by FDA		2026-10-05
excluded package	package	54473-250	54473-250-01	I	Inactivated by FDA		2026-10-05

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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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	54473-250-01	`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
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-250-01	2019-11-27	C162847	48780-1	9855e2a2-465f-60a7-e053-dbdaa90a05bd	Sei Bella Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Natural

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-250-01	Sei Bella Skin Refining Tinted MoisturizerNatural	1 in 1 BOX	LOTION	1		2
54473-250-01	Sei Bella Skin Refining Tinted MoisturizerNatural	44.4 mL in 1 TUBE	LOTION	44.4		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CARNOSINE	INACTIVE INGREDIENT	8HO6PVN24W	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CETETH-10 PHOSPHATE	INACTIVE INGREDIENT	4E05O5N49G	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
PEG/PPG-20/15 DIMETHICONE	INACTIVE INGREDIENT	06R6X77P9C	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POLYGLYCERYL-3 RICINOLEATE	INACTIVE INGREDIENT	MZQ63P0N0W	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)	INACTIVE INGREDIENT	59Z907ZB69	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
PROPYLHEPTYL CAPRYLATE	INACTIVE INGREDIENT	991Z19V2OD	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
TETRAPEPTIDE-21	INACTIVE INGREDIENT	179JUC43HU	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
TREMELLA FUCIFORMIS FRUITING BODY	INACTIVE INGREDIENT	GG8N28393G	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
VITIS VINIFERA LEAF	INACTIVE INGREDIENT	R1H893D80E	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-250	SEI BELLA SKIN REFINING TINTED MOISTURIZER NATURAL (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2	Legacy NDC, 2 package rows	20140430_8434d76d-3bad-428e-a6f2-28671b70acb9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54473-250-01	54473025001	1 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sei Bella Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Natural	Melaleuca Inc.	2014-04-30	HUMAN OTC DRUG LABEL	2