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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	2d2c58e2-0d15-4383-adae-12fc17b8ea50	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	1907126c-fd95-86e8-e063-6394a90a23ca	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	4504a10d-6130-4ec5-823a-ab970709e6d7	2025-03-20	Warnings	Exact identifier application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Eai-jr 286, Inc	30caf1dd-142d-85d3-e063-6394a90a0c88	2025-03-20	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	The Creme Shop	30a4280b-4a9f-4c18-e063-6394a90a85e6	2025-03-18	Warnings	Exact identifier application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45	ZINC OXIDE	Eai-jr 286, Inc	30a5ec14-63d7-e678-e063-6294a90abb57	2025-03-18	Warnings	Exact identifier application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Extra Shade, LLC	d197dfe3-c754-4a3d-9edd-335f3fce105c	2025-03-18	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c88e44da-0b0e-4744-8b4b-4d9d418f29d7	2025-03-18	Warnings	Exact identifier application number: M020
MDP UV BIO SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	SKINIDEA CO., LTD	3087771e-2ab8-2198-e063-6294a90a37d4	2025-03-17	Warnings	Exact identifier application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	2b38da59-b83e-4285-e063-6294a90ac6a7	2025-03-17	Warnings	Exact identifier application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	263ef8e8-e0c4-42e6-bb26-7581a437b35a	2025-03-14	Warnings	Exact identifier application number: M020
Impact Melanoma SPF 30	ZINC OXIDE	RENU LABORATORIES, LLC	f953302e-f712-129a-e053-6294a90ab9a8	2025-03-13	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