BRONZING MINERAL BEAUTY BALM SPF 15

Product NDC: 55789-2403
11-digit product format: 557892403
Labeler code: 55789
Product ID: 55789-2403_730bf52d-6063-45a8-9692-2c801ea6a9de
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE and ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Mineral Fusion Natural Brands
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-08-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 4 g/60mL; g/60mL
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	55789-2403		D	Discontinued by firm		2026-10-05
excluded package	package	55789-2403	55789-2403-1	D	Discontinued by firm		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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55789-2403-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55789-2403-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55789-2403-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55789-2403-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55789-2403-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55789-2403-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55789-2403-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55789-2403-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55789-2403-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55789-2403-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55789-2403-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55789-2403-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55789-2403-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55789-2403-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55789-2403-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55789-2403-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55789-2403-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55789-2403-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55789-2403-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55789-2403-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55789-2403-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55789-2403-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
55789-2403-1	2020-01-31	C162847	48780-1	9d75b9d0-7990-f424-e053-dadaa90a57ce	BRONZING MINERAL BEAUTY BALM SPF 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
CHAMAEMELUM NOBILE FLOWER OIL	INACTIVE INGREDIENT	UB27587839	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
COCO-CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	8D9H4QU99H	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%)	INACTIVE INGREDIENT	7Q6P4JN1QT	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
LAVANDULA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	19AH1RAF4M	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
PALMITOYL TRIPEPTIDE-5	INACTIVE INGREDIENT	2A3916MQHO	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
POMEGRANATE SEED OIL	INACTIVE INGREDIENT	0UI45XV0T6	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ROSA CANINA FLOWER OIL	INACTIVE INGREDIENT	DUY7M48I1T	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
THYME	INACTIVE INGREDIENT	CW657OBU4N	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55789-2403	BRONZING MINERAL BEAUTY BALM SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]	1	Legacy NDC	20150829_e2bc3c46-e2ab-4e47-93ec-46d15e7f9197.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRONZING MINERAL BEAUTY BALM SPF 15	Mineral Fusion Natural Brands	2015-08-28	HUMAN OTC DRUG LABEL	1