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 119 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357eee3c-1c21-5efb-e063-6294a90a4bb7	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357e75ec-473e-df76-e063-6294a90a70c7	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f2f62-904a-2234-e063-6394a90aee72	2025-12-15	Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f915a-bd77-350b-e063-6294a90ad27f	2025-12-15	Exact identifier application number: M020
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357ff025-84ad-6d77-e063-6394a90aad95	2025-12-15	Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	358021a2-235b-825b-e063-6394a90a76f5	2025-12-15	Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	35805e66-18e6-0e45-e063-6294a90afe58	2025-12-15	Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	35474ac4-8a9d-6a84-e063-6394a90a9bad	2025-12-15	Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	357e315e-8802-ad73-e063-6394a90a2495	2025-12-15	Exact identifier application number: M020
Tinted Physical Defense	TITANIUM DIOXIDE, ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	35477ed2-0875-58d5-e063-6294a90a3d5d	2025-12-15	Exact identifier application number: M020
Anti Aging Daily Protection	ZINC OXIDE	LEVERRIER, KAMILA	35465f21-8bcd-6e44-e063-6294a90a8e5f	2025-12-15	Exact identifier application number: M020
Anti Aging Daily Protection	ZINC OXIDE	LEVERRIER, KAMILA	3546d369-3435-b56a-e063-6294a90a0843	2025-12-15	Exact identifier application number: M020
Tinted Facial Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35a97770-2db9-99aa-e063-6294a90a459a	2025-12-15	Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35a9d07d-70e5-5eed-e063-6394a90aebaf	2025-12-15	Exact identifier application number: M020
Non-Tinted Sports Stick	TITANIUM DIOXIDE, ZINC OXIDE	HELTON SKIN & LASER INSTITUTE	35aa833a-19a1-99e9-e063-6394a90a840f	2025-12-15	Exact identifier application number: M020
Tinted Facial Primer	TITANIUM DIOXIDE, ZINC OXIDE	BEE NATURALS	36c3352e-fa51-19ad-e063-6394a90a591b	2025-12-15	Exact identifier application number: M020
Luminous Tinted Moisturizing	ZINC OXIDE	SKIN BOSS L.L.C.	35a8ae26-82eb-e4ca-e063-6394a90a0022	2025-12-15	Exact identifier application number: M020
Restore Tinted Moisturizing	ZINC OXIDE	SKIN BOSS L.L.C.	35a8e92e-ced2-fdcd-e063-6294a90acedc	2025-12-15	Exact identifier application number: M020
Velvet Tinted Moisturizing Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BOSS L.L.C.	35a871dc-a707-9963-e063-6294a90a4396	2025-12-15	Exact identifier application number: M020
Velvet NT Moisturizing Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN BOSS L.L.C.	35a8508d-7069-c2d6-e063-6394a90a6219	2025-12-15	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