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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	5990fe66-4fa2-06aa-e063-6294a90a5261	2026-08-21	Warnings	Exact identifier application number: M020
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	5991466a-e729-16b7-e063-6394a90a11ff	2026-08-21	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	597b78df-83cb-1b21-e063-6294a90a56a8	2026-08-20	Warnings, Adverse reactions	Exact identifier application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45	HOMOSALATE, OCTISALATE, AVOBENZONE	Stewart Charley Ventures, LLC	2fc45f85-a6f8-4893-8b34-4db5e39cb615	2026-08-20	Warnings	Exact identifier application number: M020
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Concierge Choice LLC	5980055b-493e-4763-e063-6294a90a570f	2026-08-20	Warnings	Exact identifier application number: M020
Lip Balm SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Skin Script, LLC	20c5fde7-ee8f-4b74-e063-6394a90a93ec	2026-08-19	Warnings	Exact identifier application number: M020
Aloe UP .5OZ SPF 50 MINERAL Sunscreen	ZINC OXIDE 14.69%	Aloe Care International, LLC	6ad80af3-78cd-4211-a5f2-68531aae264a	2026-08-19	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick	ZINC OXIDE	Utu Co	596e17d3-3064-1cda-e063-6294a90af963	2026-08-19	Warnings	Exact identifier application number: M020
Mineral sunscreen	MINERAL SUNSCREEN	Guangzhou Origin Beauty Cosmetics Co., Ltd.	59713657-a7ef-1aee-e063-6394a90a326e	2026-08-19	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 14.69%	The Naked Bee	f820a9be-c94d-4fd5-b202-2dda5746a82a	2026-08-18	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 20%	The Naked Bee	7dd2b1cd-e229-4eeb-8122-46fde5af1091	2026-08-18	Warnings	Exact identifier application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee52faa-64a8-4bdf-e063-6294a90a65cf	2026-08-17	Warnings	Exact identifier application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee4feb3-6966-67f9-e063-6394a90a16d5	2026-08-17	Warnings	Exact identifier application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier application number: M020
Soleil Defense Sunscreen	BROAD SPECTRUM SPF 30	AMARA MED SPA LLC	594244b1-db3b-002b-e063-6394a90a0329	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier application number: M020
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Charleston Dermatology, P.C.	59440f7f-4213-6e2b-e063-6394a90af483	2026-08-17	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