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 208 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kidspray Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	36df811b-35d2-261d-e063-6394a90aa91e	2025-06-05	Warnings	Exact identifier application number: M020
5-IN-1 TINTED FACE SUNSCREEN - FAIR	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	c0892856-cd12-4c1f-8420-866dbd0f8907	2025-06-04	Warnings	Exact identifier application number: M020
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	fbf8be03-93e2-4d7e-e053-6294a90a4fd5	2025-06-04	Warnings	Exact identifier application number: M020
EltaMD UV Clear SPF46	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	60438ec5-0b1f-45fd-8ce4-debfdbdc6721	2025-06-04	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face Sunscreen SPF 50	OCTOCRYLENE, ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b00d0efe-bf22-43a6-ba24-3d5b6ee9c5e1	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	2ea86aa8-2f28-40bb-9318-fec188f66010	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b59a3b67-0e44-426d-9379-0ca31628937a	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun EthoSport Stick Broad Spectrum SPF 40	ZINC OXIDE	EthoSun, Inc	35372859-8f40-5eb0-e063-6294a90a6a00	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45	ZINC OXIDE	EthoSun, Inc	d7d2bca6-5000-4cb9-b004-b1ae286f6035	2025-06-03	Warnings	Exact identifier application number: M020
Age Defense for Eyes 5 in 1	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	48d5343a-1068-4c64-a275-c180026d6947	2025-06-03	Warnings	Exact identifier application number: M020
Ola Botanicals Sunscreen SPF 30	ZINC OXIDE	Natural Health Partners, LLC	c7a7df0b-da8f-407d-a1ee-28f75070b23c	2025-06-02	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	95ea5442-a7ca-0c7d-e053-2a95a90ad247	2025-06-02	Warnings	Exact identifier application number: M020
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	31f1e961-3719-f70a-e063-6394a90a481e	2025-05-31	Warnings	Exact identifier application number: M020
Sunny Sailor First Mate Face Stick SPF 30	ZINC OXIDE	SUNNY SAILOR LLC	8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e	2025-05-28	Warnings	Exact identifier application number: M020
Dr Mercola Broad Spectrum SPF15	ZINC OXIDE	Natural Health Partners, LLC	47f6b19e-ede8-0daf-e054-00144ff88e88	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	ZINC OXIDE	Natural Health Partners, LLC	47f6ec0a-1144-55dd-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	Natural Health Partners, LLC	47f6ab9e-fa73-496a-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Celavive Protective Day SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	USANA Health Sciences, Inc.	cf00763f-6b3e-4d50-b639-9a6d6f595961	2025-05-28	Warnings	Exact identifier application number: M020
TALLOW SUNSCREEN	NON-NANO ZINC OXIDE	FOUNDATION COMMERCE INC	363e38bf-b4b4-dcc4-e063-6294a90a5d2f	2025-05-28	Warnings	Exact identifier application number: M020
CoreTex SunX 50 Facestick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	364989ea-c93b-d404-e063-6294a90abd09	2025-05-28	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