Mineral Moisture Defense SPF 50

Product NDC: 49358-583
11-digit product format: 493580583
Labeler code: 49358
Product ID: 49358-583_36d86ec1-c64d-d417-e063-6394a90a5f9f
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 20; 170 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 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
2025-04-01 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	49358-583-01	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	49358-583-01	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	49358-583-01	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	49358-583-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49358-583-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49358-583-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49358-583-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Mineral Moisture Defense SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	20 mg/mL
ZINC OXIDE	170 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
05ad73f3-a4e8-4f78-8212-3e8e3bda988c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
49358-583-01	2025-06-05	C162847	48780-1	2cef2736-961a-d83d-e063-dadaa90ab31f	Mineral Moisture Defense SPF 50 Broad Spectrum SPF 50 Sunscreen Water Resistant (80 min)
49358-583-01	2025-01-30	C162847	48780-1	2cef2736-961a-d83d-e063-dadaa90ab31f	Mineral Moisture Defense SPF 50 Broad Spectrum SPF 50 Sunscreen Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-583-01	Mineral Moisture Defense SPF 50	1 in 1 CARTON	CREAM	1		2
49358-583-01	Mineral Moisture Defense SPF 50	100 mL in 1 TUBE	CREAM	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-583	MINERAL MOISTURE DEFENSE SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230922_05ad73f3-a4e8-4f78-8212-3e8e3bda988c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 146 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safe Sea SPF sport 65	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	0ed3242b-ac35-4d98-a777-1e44bb32a467	2025-12-08	Warnings	Exact identifier application number: M020
Safe Sea SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	46641a33-d658-4ef0-9b7a-062adc401dde	2025-12-08	Warnings	Exact identifier application number: M020
Skin Filter Glow SPF	ZINC OXIDE	MALORIE MILES	36485f44-a6bd-9529-e063-6294a90af7a4	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3647f983-9e75-8955-e063-6294a90af162	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	36499be5-d680-92bf-e063-6394a90a89db	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3649f758-e31b-3c6a-e063-6294a90a5c36	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	364ae392-480a-14ea-e063-6394a90a3883	2025-12-08		Exact identifier application number: M020
Personalized Moisturizer SPF 30	ZINC OXIDE 10.00%	Proven Skincare	d3cf8f81-d6ae-4570-ad86-43415e973e13	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2f9d087c-b2b3-5654-e063-6294a90a94e5	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faee7ef-fc0c-6d01-e063-6294a90a6d68	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faf530d-5574-b702-e063-6294a90ad6fd	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2fb00db0-4c37-56c6-e063-6294a90a8aff	2025-12-08	Warnings	Exact identifier application number: M020
Matte Shield SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE SOLUTIONS NYC INC	3bb582ec-71e7-4ad8-e063-6394a90a94d4	2025-12-08	Warnings	Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334afdc8-1e12-d787-e063-6294a90aed7c	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334bf8ea-2485-84e8-e063-6294a90aefa6	2025-12-08		Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334d694a-f9e4-ae86-e063-6394a90abfe1	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334e32a4-c3a5-e37d-e063-6294a90ad6cf	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245561d-a90c-7bf0-e063-6394a90ab3b6	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245c1f7-2c1b-b6ad-e063-6394a90aaee6	2025-12-08		Exact identifier application number: M020
Mineral Based Facial Sunscreen	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3e8981ed-5847-7009-e063-6394a90a49a1	2025-12-08	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49358-583-01	49358058301	1 TUBE in 1 CARTON (49358-583-01) / 100 mL in 1 TUBE	1 tube	2023-07-01	No	No	Current