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 122 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extreme Protection Non Tinted	ZINC OXIDE	BIOHEALTH PLUS LLC	3764cbeb-55f5-4a9c-e063-6394a90a863d	2025-12-15		Exact identifier application number: M020
Happy Mineral Sunscreen Primer SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE CLINIC LAS VEGAS BY JUSTINA	37d9c5f2-f414-6efa-e063-6294a90a927f	2025-12-15		Exact identifier application number: M020
Comfort Mineral Mousse Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	3765dd17-ffbd-bcf4-e063-6394a90a2c2b	2025-12-15		Exact identifier application number: M020
Prime And Protect Dewy	ZINC OXIDE	Kalon Skin Studio, LLC	3593cefe-a08f-eb88-e063-6394a90aaff6	2025-12-15		Exact identifier application number: M020
Glow	ZINC OXIDE	GODDESSLYNNEBODYANDSKIN	37247365-33ee-563d-e063-6394a90a249e	2025-12-15		Exact identifier application number: M020
Prime And Protect Matte	TITANIUM DIOXIDE, ZINC OXIDE	Kalon Skin Studio, LLC	35939630-1166-1c70-e063-6294a90aac6b	2025-12-15		Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36d9d83b-7da5-a006-e063-6394a90a9d84	2025-12-15		Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36da1a55-c076-cdd9-e063-6294a90ac97c	2025-12-15		Exact identifier application number: M020
Tinted Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Goldberg, Howard S MD Inc	3598205d-2e87-9292-e063-6294a90a1f2a	2025-12-15		Exact identifier application number: M020
Tinted Daily Replenishing Protection	ZINC OXIDE	Goldberg, Howard S MD Inc	3597dccf-07a1-5cd9-e063-6294a90aca71	2025-12-15		Exact identifier application number: M020
Hydrating Mineral Zinc Oxide SPF 40	ZINC OXIDE	Spalina LLC.	35aa74c5-1bb3-9814-e063-6294a90a6999	2025-12-15		Exact identifier application number: M020
Mineral Tinted SPF40 with ceramides	ZINC OXIDE	Spalina LLC.	35ac3bd1-a4c1-5078-e063-6394a90afdc8	2025-12-15		Exact identifier application number: M020
Suns Out Funs Out	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	46040acf-512e-c867-e063-6294a90ac220	2025-12-15	Warnings	Exact identifier application number: M020
Advanced Formula Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3981c878-826d-f685-e063-6294a90acb24	2025-12-15		Exact identifier application number: M020
Advanced Formula Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3984c4b7-94ee-2a8e-e063-6294a90ac24f	2025-12-15		Exact identifier application number: M020
Ultra Tinted Protection	TITANIUM DIOXIDE, ZINC OXIDE	CLEAR SKIN SOLUTIONS, LLC	35bc833d-f231-5f52-e063-6394a90a37a6	2025-12-15		Exact identifier application number: M020
Ultra Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CLEAR SKIN SOLUTIONS, LLC	35bc4586-5e62-c9e7-e063-6294a90a276b	2025-12-15		Exact identifier application number: M020
20Percent Zinc Total Protection	ZINC OXIDE	CLEAR SKIN SOLUTIONS, LLC	35bcaee1-001b-82da-e063-6394a90a4a0f	2025-12-15		Exact identifier application number: M020
Advanced Formula Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	39821730-f6d1-c01a-e063-6394a90a026b	2025-12-15		Exact identifier application number: M020
Advanced Formula Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CR KEEFE ENTERPRISES, INC.	3984920a-feb9-169c-e063-6394a90a9568	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