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 3 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Wave Anti Aging Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7e48a3d2-e453-4733-b42b-8bea804cda59	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7204c24f-aab6-45eb-9bd4-879f715ba075	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7c1e780a-1831-4f49-a92e-e36017d241a2	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	d45614c8-b09c-417b-b691-082ea2149880	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	999b0b17-be73-4d42-b182-ce038f493301	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	adffff46-4cfb-4c0a-b1a6-75220ee193a5	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	13b2b45b-70e1-46ff-8555-48e1fe98c651	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Kids Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	5c2a5ca3-e9eb-48ba-8698-592d2c7aa241	2026-09-01	Warnings	Exact identifier application number: M020
Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c408728-a1de-d51e-e063-6294a90ade0b	2026-08-31	Warnings	Exact identifier application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Craver Corporation	38d8c1c9-86b5-1edd-e063-6394a90aeb47	2026-08-30	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a3a17ff-a7fd-f707-e063-6394a90a3182	2026-08-29	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	5a3a59b2-18b6-521b-e063-6294a90a2958	2026-08-29	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	f5eb347f-0d46-4de6-8f3f-9010327678ed	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen	ZINC OXIDE	Utu Co	59938ace-c97c-d758-e063-6394a90a77e4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented	ZINC OXIDE	Utu Co	5982e790-7cdb-c96c-e063-6394a90a02d4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50	ZINC OXIDE	Utu Co	59d1d0ac-2444-d6f9-e063-6294a90ae80c	2026-08-28	Warnings	Exact identifier application number: M020
Hello Bello Mineral Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	54f12764-5c37-4a05-bf96-209fedb93fd1	2026-08-28	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a02c540-5b3b-9379-e063-6294a90a00f6	2026-08-27	Warnings	Exact identifier application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier application number: M020
Round Lab Holiday Heroes Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	5a0d3a85-caff-a90d-e063-6394a90ad045	2026-08-27	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
49358-577-01	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