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 112 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brightening Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	a42d6761-47cd-4c9b-9656-64e37e065639	2025-12-17	Warnings	Exact identifier application number: M020
Avail Body with Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Emeis Cosmetics Pty Ltd	4bb39ea1-f948-4357-b425-0cafd454ce30	2025-12-17	Warnings	Exact identifier application number: M020
Bronzing Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	f749af07-0fcd-4376-be62-7c078b3e7eb6	2025-12-17	Warnings	Exact identifier application number: M020
Miffy Tone Perfecting SPF Cushion	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	RBGROUP Co., Ltd	98a2906d-61e2-4627-a695-a20f10872f9a	2025-12-16	Warnings	Exact identifier application number: M020
Dear Sun Tone Perfecting SPF Cushion	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	RBGROUP Co., Ltd	80748647-e0ea-46dc-8ee2-a0ad77c4b19d	2025-12-16	Warnings	Exact identifier application number: M020
SUNSCREEN Stick	ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	460e1038-30f0-a6e4-e063-6394a90ad534	2025-12-16	Warnings	Exact identifier application number: M020
SUNSCREEN SPRAY150ml	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	460ead6c-dd44-e320-e063-6294a90a2b64	2025-12-16	Warnings	Exact identifier application number: M020
Sunscreen Cream	ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%	Foshan Sugar Max Cosmetics CO.,Ltd	460f0ca0-9440-9a6e-e063-6394a90a33b3	2025-12-16	Warnings	Exact identifier application number: M020
Unseen Sunscreen Lip Protector SPF 30	OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE	Supergoop LLC	db12a89f-5fef-1b2a-e053-2a95a90a56f9	2025-12-16	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	Natur LLC	365f3c48-15a6-2d32-e063-6394a90aad78	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	ZINC OXIDE	Natur LLC	365fffa2-b846-7dd3-e063-6394a90a47cb	2025-12-16		Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	Natur LLC	36603550-9c3d-5e33-e063-6394a90adfc9	2025-12-16		Exact identifier application number: M020
Shield And Protect Tinted	ZINC OXIDE	TRILOGY LABORATORIES, LLC	37f00e51-1123-c04c-e063-6294a90abed8	2025-12-16		Exact identifier application number: M020
Shield And Protect	ZINC OXIDE	TRILOGY LABORATORIES, LLC	37f09dd5-084f-3c80-e063-6394a90a7a53	2025-12-16		Exact identifier application number: M020
Non Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766496f-231c-f98c-e063-6294a90aae08	2025-12-16		Exact identifier application number: M020
Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766b0d8-20e6-a227-e063-6294a90af4da	2025-12-16		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	ZINC OXIDE	WECARE FRISCO PLLC	37515807-e29a-3916-e063-6394a90a1ffd	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	374f866d-eb52-61e3-e063-6394a90a77c7	2025-12-16		Exact identifier application number: M020
Tinted Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	3750c23d-c3f8-fac3-e063-6394a90a135e	2025-12-16		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40	ZINC OXIDE	WECARE FRISCO PLLC	374fe86e-cbe8-f911-e063-6294a90a9600	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