Solar SPF 40

Product NDC: 49358-577
11-digit product format: 493580577
Labeler code: 49358
Product ID: 49358-577_36d8788d-8533-df6d-e063-6394a90add46
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 81; 60 mg/g; mg/g
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	49358-577-01	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	49358-577-01	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	49358-577-01	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	49358-577-01	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	49358-577-01	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	49358-577-01	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	49358-577-01	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: Solar SPF 40
Brand name suffix: Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	81 mg/g
ZINC OXIDE	60 mg/g

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
6ce602bb-c1f4-43c1-ae61-0f05d7952db3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49358-577-01	2025-06-05	C162847	48780-1	2cef2736-b6a3-d83d-e063-dadaa90ab31f	Solar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen
49358-577-01	2025-01-30	C162847	48780-1	2cef2736-b6a3-d83d-e063-dadaa90ab31f	Solar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-577-01	Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	1 in 1 CARTON	STICK	1		2
49358-577-01	Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	17 g in 1 TUBE	STICK	17		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-577	SOLAR SPF 40 BROAD SPECTRUM SPF 40 WATER RESISTANT (80 MIN) MINERAL SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230912_6ce602bb-c1f4-43c1-ae61-0f05d7952db3.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 115 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f68b2ea-be23-100d-e063-6294a90a8b37	2025-12-16	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	ISIS GONZALEZ	3f682b78-e1c9-e174-e063-6294a90a17ed	2025-12-16	Warnings	Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3793a-ccb5-1e5f-e063-6294a90ad44f	2025-12-16		Exact identifier application number: M020
Silk Screen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Science Institute Inc	36c3a721-6be1-3f7f-e063-6394a90a522f	2025-12-16		Exact identifier application number: M020
True Tone Tinted	TITANIUM DIOXIDE, ZINC OXIDE	That Face PLLC	36c2bb0e-479d-89cd-e063-6294a90aa3d4	2025-12-16		Exact identifier application number: M020
True Tone Non Tinted	ZINC OXIDE	That Face PLLC	36c2f263-67cf-e8cf-e063-6394a90ad81f	2025-12-16		Exact identifier application number: M020
Tinted Daily Protection Sunscreen	ZINC OXIDE	Kemmi Lee Skin Science	37ef5a05-54d2-a8e4-e063-6394a90a8e48	2025-12-16		Exact identifier application number: M020
Aquaphor Lip Repair Stick and Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Beiersdorf Inc	d469bddf-90d4-7b1c-e053-2a95a90a1ed9	2025-12-16	Warnings	Exact identifier application number: M020
Eucerin Daily Protection Face	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Beiersdorf Inc	76403f03-aee9-4c0b-b331-f79b6953118c	2025-12-16	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0400b-8ad9-654b-e063-6294a90ad040	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c00301-ee41-333c-e063-6294a90a61d5	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c078fa-05f9-ad80-e063-6394a90af3bb	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c108f6-a928-0a54-e063-6394a90ae686	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0ccca-c993-181e-e063-6294a90a7ae6	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0a55d-16d3-086a-e063-6394a90a30cf	2025-12-16		Exact identifier application number: M020
Eucerin Radiant Tone	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	2611e0cb-d56d-6ea1-e063-6294a90a745b	2025-12-16	Warnings	Exact identifier application number: M020
Really Great Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c1341d-fbf5-56a5-e063-6294a90aa045	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	KLOE SALON LLC	36c23c07-2011-3ddb-e063-6294a90a76e9	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sun Defense	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c465ea-979b-9474-e063-6394a90ab3f8	2025-12-16		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c4a27b-96e9-4f30-e063-6294a90a5655	2025-12-16		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
49358-577-01	49358057701	1 TUBE in 1 CARTON (49358-577-01) / 17 g in 1 TUBE	1 tube	2023-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen	MDSolarSciences	2025-06-05	HUMAN OTC DRUG LABEL	2