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 217 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Sport 100 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	0a245b1b-eaf6-7011-e063-6294a90ab68f	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Apple Pie flavored	LIP BALM SPF15 APPLE PIE FLAVORED	LS Promotions Inc	3145bd6d-0ece-e9d5-e063-6294a90afb9d	2025-03-26	Warnings	Exact identifier application number: M020
HEB Glow 40 Tinted Sunscreen Face Primer	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B.	3146bcd9-d562-9ba6-e063-6294a90a37aa	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	3146fb5f-1fb5-f09f-e063-6294a90a6206	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Glow Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	31473cc9-08f5-39e3-e063-6294a90aa499	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	314776a8-a562-3dd2-e063-6394a90ab1b9	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	31478f5a-88f4-4b01-e063-6394a90a04b7	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	3147c08f-c3f2-aef1-e063-6294a90a5c44	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mangonada Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	3147ef18-9029-6d5b-e063-6394a90acee0	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	31487bad-a756-9050-e063-6394a90acacc	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40	ZINC OXIDE	Trader Joe's Company	3148c00f-21bb-c05f-e063-6394a90af0e8	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314b8147-fe7a-0698-e063-6394a90a872c	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314bcf42-ca01-0fa5-e063-6294a90a5fc8	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	1e5d494b-dccf-4ba1-89de-0bb4ba5b8d38	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Murad, LLC	ac6163fb-dbc1-432f-a590-86d31c93b29b	2025-03-26	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral Medium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e17dc640-30e9-441b-a212-ef1508af7944	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Vanilla	LIP BALM SPF15 VANILLA	LS Promotions Inc	312d0dc5-3933-ecfe-e063-6294a90a9b66	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Blueberry Cobbler	LIP BALM SPF15 BLUEBERRY COBBLER	LS Promotions Inc	312fb7b0-86a9-ca88-e063-6294a90a76c8	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Peppermint	LIP BALM SPF15 PEPPERMINT	LS Promotions Inc	3130be1c-0167-2389-e063-6394a90aa61d	2025-03-25	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 30	SUNSCREEN SPF 30	OL PHARMA TECH LLC. (Drs. Pharmacy)	052dea5d-a775-8dc2-e063-6294a90a4f19	2025-03-25	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