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 332 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIDEFUL SPF 15 LIP BALM-passion fruit	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	d6b6389b-c8bd-4aca-8ccf-455dbc22070d	2023-10-26	Warnings	Exact identifier application number: M020
PRIDEFUL SPF 15 LIP BALM-coconut	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	a6af5cdc-999d-45ba-a7a6-5e7330f8b9c0	2023-10-26	Warnings	Exact identifier application number: M020
PRIDEFUL SPF 15 LIP BALM-melon	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	e201fec6-eb69-40fb-8459-02d64e34a3b7	2023-10-26	Warnings	Exact identifier application number: M020
PRIDEFUL SPF 15 LIP BALM-orange mango	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	PRIDEFUL LLC	c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf	2023-10-26	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	e5fcb1fd-ad61-1ea5-e053-2a95a90a2472	2023-10-26	Warnings	Exact identifier application number: M020
Grape Soda SPF 15 Broad Spectrum Lip Balm	GRAPE SODA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a09a0b5f-93e4-d18a-e053-2a95a90a65f7	2023-10-26	Warnings	Exact identifier application number: M020
Beeswax SPF 30 Broad Spectrum Lip Balm	BEESWAX SPF 30 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a962bfca-03a3-8dde-e053-2a95a90abbb9	2023-10-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	Oxygen Development LLC	08a1e862-b55a-fb84-e063-6294a90a016a	2023-10-26	Warnings	Exact identifier application number: M020
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	THE KROGER COMPANY	a52872bf-cd0f-06da-e053-2995a90af28d	2023-10-26	Warnings	Exact identifier application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30	ZINC OXIDE	Babo Botanicals, Inc.	08a36887-3997-8fff-e063-6394a90ae9d5	2023-10-26	Warnings	Exact identifier application number: M020
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45	TITANIUM DIOXIDE AND ZINC OXIDE	ESTEE LAUDER INC	e87c4a76-5f21-4989-a1e0-0b7c6902f201	2023-10-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Unflavored Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALM	Raining Rose	efe20472-aa84-1cb4-e053-2a95a90abfd8	2023-10-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Mint Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALM	Raining Rose	efe1113b-6101-0c15-e053-2a95a90a02a7	2023-10-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALM	Raining Rose	efe176f7-9c11-106e-e053-2a95a90a9c88	2023-10-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Citrus Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALM	Raining Rose	efdfc182-3ac0-1a3d-e053-2a95a90a894e	2023-10-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALM	Raining Rose	efe01abd-0ee2-6bd6-e053-2a95a90a123d	2023-10-26	Warnings	Exact identifier application number: M020
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	NATURA BISSE INTERNATIONAL SA	bf8b71c7-257b-0eb6-e053-2a95a90a3a4c	2023-10-26	Warnings	Exact identifier application number: M020
Carmex Weather Guard Moisturizing Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Carma Laboratories, Inc.	843677f2-78fa-4f3d-9fe6-e45e35b728e3	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baec9be7-5ae6-135c-e053-2995a90a2ed4	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baea3596-6eb0-4d98-e053-2995a90a75cc	2023-10-25	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