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 72 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE AVON COMPANY	48e8b7f5-6977-bfae-e063-6394a90a888b	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	32725ca7-ec21-4643-bdc6-278fd647b95d	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	e6877f7a-3aaa-4096-bcb5-eae0aa2532e5	2026-01-21	Warnings	Exact identifier application number: M020
MINICELL UV SHIELD SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CELINA CO., LTD.	48eff8fa-deec-a434-e063-6294a90aa861	2026-01-21	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 30	ZINC OXIDE	Delta Ecommerce LLC	47dbcf07-7e3a-e3de-e063-6294a90a2c21	2026-01-21	Warnings	Exact identifier application number: M020
sunscreen	TITANIUM DIOXIDE	Guangdong Zhoubang Biotechnology Co., Ltd	48f13b1c-8104-881b-e063-6394a90a816d	2026-01-21	Warnings	Exact identifier application number: M020
Sunscreen lip balm	ETHYLHEXYL SALICYLATE	Guangdong Zhoubang Biotechnology Co., Ltd	48f1ee5c-33d0-818c-e063-6294a90a1e59	2026-01-21	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Mother	CEILE SPF 30 PRIME PROTECT RADIATE MOTHER	LE COSMETICS INC	490db6ef-d7f2-446c-e063-6294a90af303	2026-01-21	Warnings	Exact identifier application number: M020
DewyVita Zero Spot Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	BAREUNPLAN CO.,LTD.	497c98c3-d809-52e0-e063-6294a90acca2	2026-01-21	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	OCTINOXATE, OXYBENZONE, AVOBENZONE	Bentley Laboratories LLC	4c0b4733-96ea-4b1d-8a7b-13af66cc28d0	2026-01-21	Warnings	Exact identifier application number: M020
Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	RV Skincare LLC	86b46c9b-6573-439b-b38b-2d76d495df6d	2026-01-20	Warnings	Exact identifier application number: M020
Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	RV Skincare LLC	1b8cf189-0d06-4e86-bd7b-b77a638f1670	2026-01-20	Warnings	Exact identifier application number: M020
Bella s Friends SPF50 Sunscreen	ZINC OXIDE	PANERGYTEKUSAINC	48ce4ef7-e24a-4894-e063-6294a90a49c8	2026-01-20	Warnings	Exact identifier application number: M020
Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	93a27f09-14e2-47a0-ac5f-4d3425e31ec9	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	d00b978d-1682-4cde-ae5f-189e677136c4	2026-01-20	Warnings	Exact identifier application number: M020
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer	ZINC OXIDE	Clean Beauty For All, Inc	b6bfd636-2f46-3fca-e053-2a95a90a05a6	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	19230647-29a3-d209-e063-6394a90aae36	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	8e2a2046-13e6-4a40-a0bc-65c979c59b93	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	dbc4242a-3651-48be-bfc6-c595be5a2a15	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922f11d-10ce-82b4-e063-6394a90a6650	2026-01-20	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