Mineral Tinted SPF 30

Product NDC: 49358-571
11-digit product format: 493580571
Labeler code: 49358
Product ID: 49358-571_36d86ec1-c63c-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	49358-571-01	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	49358-571-01	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	49358-571-01	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	49358-571-01	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	49358-571-01	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	49358-571-01	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	49358-571-01	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 Tinted SPF 30
Brand name suffix: Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
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
adcd6881-fa25-4312-95e5-5b47102aa6b9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49358-571-01	2025-06-05	C162847	48780-1	2cef2736-6b69-d83d-e063-dadaa90ab31f	Mineral Tinted Crème SPF 30 Mineral Tinted Crème SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
49358-571-01	2025-01-30	C162847	48780-1	2cef2736-6b69-d83d-e063-dadaa90ab31f	Mineral Tinted Crème SPF 30 Mineral Tinted Crème SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-571-01	Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	1 in 1 CARTON	CREAM	1		2
49358-571-01	Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	50 mL in 1 TUBE	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-571	MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230910_adcd6881-fa25-4312-95e5-5b47102aa6b9.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 110 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DAY DEFENSE TINTED	TITANIUM DIOXIDE, ZINC OXIDE	THE SKIN CARE SOURCE, INC.	36ad4442-e45f-90e2-e063-6294a90aeef5	2025-12-17		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	HSC MIAMI, INC	36d8b849-cf73-e008-e063-6394a90a410a	2025-12-17		Exact identifier application number: M020
TINTED RESTORATIVE MOISTURIZER	ZINC OXIDE	SKINERGIX LLC	3636adf0-c3bd-7422-e063-6394a90aaccc	2025-12-17		Exact identifier application number: M020
Premier Zinc	ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3bb378c8-14b0-aa13-e063-6294a90a4db3	2025-12-17	Warnings	Exact identifier application number: M020
Protect and Renew	ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3bb479ed-1153-8e80-e063-6294a90a2937	2025-12-17	Warnings	Exact identifier application number: M020
Flawless Finish	TITANIUM DIOXIDE, ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3b8df7ce-e5ce-aaf8-e063-6394a90afdae	2025-12-17	Warnings	Exact identifier application number: M020
Shield Mineral Sunscreen Tinted	ZINC OXIDE	SMOOTHE LLC	369b9d76-f6c3-e25f-e063-6294a90adaf3	2025-12-17		Exact identifier application number: M020
Shield Mineral Sunscreen Non Tinted	ZINC OXIDE	SMOOTHE LLC	369bc20d-7192-7c0a-e063-6294a90a3dfe	2025-12-17		Exact identifier application number: M020
Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369d63a9-b9a9-9530-e063-6394a90ac8ef	2025-12-17		Exact identifier application number: M020
Matte Tint	TITANIUM DIOXIDE, ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369ced69-59b4-0f3c-e063-6294a90a582f	2025-12-17		Exact identifier application number: M020
Hydra Tint	ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369d4e7a-8356-8f15-e063-6394a90acca8	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b0ac77-13d8-4259-e063-6394a90a893b	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b000e3-2516-932c-e063-6294a90a0e41	2025-12-17		Exact identifier application number: M020
Moisturizing Mineral Sunscreen Tinted	ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b12dbc-5edc-aad1-e063-6394a90a42ea	2025-12-17		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b1a6c8-b4ff-089a-e063-6394a90a2469	2025-12-17		Exact identifier application number: M020
Badger SPF 40 Tinted Mineral Face	ZINC OXIDE	W.S. Badger Company, Inc.	4628c04f-b7a6-b3fe-e063-6294a90a1675	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a4d0e-8ab2-3d79-e063-6394a90a7006	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a42a3-6fe4-2980-e063-6394a90a54fe	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Glow Suncreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdord Inc	b65c117d-f200-bb22-e053-2995a90ab71d	2025-12-17	Warnings	Exact identifier application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades	ZINC OXIDE AND TITANIUM DIOXIDE	Noxell	2cdbeb73-b805-f144-e063-6294a90a088d	2025-12-17	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
49358-571-01	49358057101	1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE	1 tube	2023-07-01	No	No	Current