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 142 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Sunscreen Dry Touch NT	TITANIUM DIOXIDE, ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	334ffc49-3196-0995-e063-6394a90ad559	2025-12-09		Exact identifier application number: M020
Foam Weightless Sunscreen Non-Tinted Drytouch NT	TITANIUM DIOXIDE, ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	335ec22c-6a9a-c4d1-e063-6394a90ac0b0	2025-12-09		Exact identifier application number: M020
Mineral Sunscreen Moisturizing Non-Tinted	ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	3360a208-5f17-a74b-e063-6294a90a13e1	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	323356ea-31a0-6ff0-e063-6294a90a135c	2025-12-09		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32330376-5db0-202b-e063-6294a90add15	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Untinted	ZINC OXIDE	Lily Lee, MD	32354468-94a2-604b-e063-6394a90adfb5	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Tinted	ZINC OXIDE	Lily Lee, MD	32346536-f542-ef0f-e063-6394a90a0464	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Mineral Stick Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	3234b498-5b56-55f4-e063-6294a90a9b87	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Tinted	ZINC OXIDE	Lily Lee, MD	3235a696-92aa-788c-e063-6394a90a0149	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32351db0-884c-8fa0-e063-6294a90acba2	2025-12-09		Exact identifier application number: M020
Sunscreen Plus Untinted	ZINC OXIDE	Lily Lee, MD	3235786d-7ba9-c9ab-e063-6294a90a7f2e	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	31416d04-2d6f-7cf9-e063-6294a90a9806	2025-12-09	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen Non-Tinted	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3143968a-096e-b9ac-e063-6294a90ada0d	2025-12-09	Warnings	Exact identifier application number: M020
Daily Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	314299b1-a78b-c1bd-e063-6294a90ab43b	2025-12-09	Warnings	Exact identifier application number: M020
Sheer Satin Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3143d8b0-4af8-f52d-e063-6294a90a926b	2025-12-09	Warnings	Exact identifier application number: M020
Matte Invisible Mineral Sunscreen	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3142ed0f-f379-f240-e063-6294a90a5303	2025-12-09	Warnings	Exact identifier application number: M020
Sheer Non-Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33d83cfb-045d-141c-e063-6394a90a2e04	2025-12-09		Exact identifier application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	45875865-5e9c-d652-e063-6394a90ad5fa	2025-12-09	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b7584-c782-fe9e-e063-6394a90a76fe	2025-12-09		Exact identifier application number: M020
Transparent Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33dbfd9b-b90f-bb32-e063-6294a90af7dc	2025-12-09		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