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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc0ff10-fb2f-e637-e053-6294a90a0c29	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984c64f-eaac-ecb6-e063-6394a90aeb12	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984a014-a56f-753b-e063-6294a90a13f5	2024-12-26	Warnings	Exact identifier application number: M020
Julep No Excuses Gel for Face SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	298404c4-d4be-7395-e063-6294a90a86bf	2024-12-26	Warnings	Exact identifier application number: M020
Cover FX Invisible Primer SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2983dd7c-7ca7-e952-e063-6394a90a3098	2024-12-26	Warnings	Exact identifier application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUM	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, INC	2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e	2024-12-26	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	30b224f0-43f1-4c79-839e-3a970e4be3a5	2024-12-26	Warnings	Exact identifier application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN	HOMOSALATE, OCTISALATE, AND AVOBENZONE	CLINIQUE LABORATORIES LLC	f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444	2024-12-25	Warnings	Exact identifier application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	ESTEE LAUDER INC	0770e251-95d0-43de-88f1-bc0a29811e4e	2024-12-25	Warnings	Exact identifier application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	MAKEUP ART COSMETICS	c26ef380-1309-4a41-862f-eb319d38673d	2024-12-25	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	ff48435d-245a-4037-9afb-caee83c4c415	2024-12-25	Warnings	Exact identifier application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40	OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	0fe63edf-7a49-4b33-88f1-f480f889d194	2024-12-25	Warnings	Exact identifier application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	8e8c495e-d439-4735-a7cc-b44081b75b27	2024-12-25	Warnings	Exact identifier application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0fac5204-df18-4774-bb53-115513cb7ff0	2024-12-25	Warnings	Exact identifier application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20	TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	66e48ce0-9a5b-4250-b07b-1622b3814c3e	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	2f93580c-c8e9-4822-91bf-a749cf4deb4e	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cab9-1b3e-e063-6394a90afe5d	2024-12-25	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