Hydrating Sheer Lip Balm SPF 30 - BARE

Product NDC: 49358-601
11-digit product format: 493580601
Labeler code: 49358
Product ID: 49358-601_36d8ea31-6d00-0d8f-e063-6394a90ae824
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, and Homosalate
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength: 30; 50; 100 mg/g; 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	49358-601-01	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	49358-601-01	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	49358-601-01	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	49358-601-01	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	49358-601-01	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	49358-601-01	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	49358-601-01	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: Hydrating Sheer Lip Balm SPF 30 - BARE
Brand name suffix: Broad Spectrum SPF 30 UVA-UVB Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	30 mg/g
OCTISALATE	50 mg/g
HOMOSALATE	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	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
0f23441c-2399-4a72-9f0a-420d25db78af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49358-601-01	2025-06-05	C162847	48780-1	2cef2736-5aef-d83d-e063-dadaa90ab31f	Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen
49358-601-01	2025-01-30	C162847	48780-1	2cef2736-5aef-d83d-e063-dadaa90ab31f	Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-601-01	Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen	1 in 1 CARTON	LIPSTICK	1		2
49358-601-01	Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen	4.2 g in 1 APPLICATOR	LIPSTICK	4.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-601	HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230922_0f23441c-2399-4a72-9f0a-420d25db78af.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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEDICUBE PDRN SILKY SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	APR US INC	57154bec-6714-0314-e063-6294a90a4bd0	2026-07-20	Warnings	Exact identifier application number: M020
TOCOBO Double UV Defense Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON Co., Ltd.	56aff65a-aa08-dc3f-e063-6294a90acac3	2026-07-19	Warnings	Exact identifier application number: M020
THE SPORTO Invisible Sport for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	46564a09-909d-bcc7-e063-6294a90a627b	2026-07-17	Warnings	Exact identifier application number: M020
RR Sun Creme	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	dc60b685-a7fc-47bb-ade9-44a8e3b54812	2026-07-17	Warnings	Exact identifier application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	0ef2ebae-7198-47f4-8891-d1ca3cf54d4b	2026-07-16	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	PMI Branded Pharmaceuticals, Inc.	f9be5adb-dce3-4b17-939f-d80d486f2cb0	2026-07-16	Warnings	Exact identifier application number: M020
BaseLife Pure Mineral Shield Sunscreen	ZINC OXIDE	Wintech America, Inc.	7f741a91-6ed8-4d08-9196-d15527d044d5	2026-07-15	Warnings	Exact identifier application number: M020
BaseLife Clear UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wintech America, Inc.	128db446-93ba-4347-bd39-66177572c659	2026-07-15	Warnings	Exact identifier application number: M020
Biore Aqua Rich Facial Mist SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	Kao USA Inc.	56a80a0d-b0b5-1098-e063-6294a90a5270	2026-07-15	Warnings	Exact identifier application number: M020
Anti Aging Lip Balm Pot SPF 15	LIP BALM	Epicuren Disocovery	4097e28a-ed11-e16a-e063-6294a90a5e9b	2026-07-14	Warnings	Exact identifier application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50	ZINC OXIDE	CALM ENTERPRISE LLC	722462d8-d2ab-44ce-9065-673ab2076269	2026-07-14	Warnings	Exact identifier application number: M020
X-Treme Cream Propolis Sunscreen SPF 45	X-TREME CREAM	Epicuren Discovery	3b29976e-eee0-b978-e063-6294a90accd6	2026-07-14	Warnings	Exact identifier application number: M020
Anti-Aging Lip Balm SPF 15	LIP BALM	Epicuren Discovery	3cbd0550-b6e5-3e86-e063-6394a90ac07f	2026-07-14	Warnings	Exact identifier application number: M020
Zinc Oxide Perfecting Sunscreen	ZINC OXIDE	Epicuren Discovery	1a0228f9-bf3f-a1fe-e063-6294a90a3fb5	2026-07-14	Warnings	Exact identifier application number: M020
Vacation Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	14b8a3cf-031c-4c52-ba81-e683e69d0f37	2026-07-14	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	L. Perrigo Company	bd5c9df7-8dfb-4d20-9966-e148c5667b22	2026-07-14	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	4081a4ad-b738-5fb6-e063-6394a90a9171	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc5c1d8-91f8-8ad2-e063-6294a90a9229	2026-07-13	Warnings	Exact identifier application number: M020
Olay Super Serum Body Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	5513c5e2-3baf-2f09-e063-6394a90a495a	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc48592-f70d-664e-e063-6294a90ac6e8	2026-07-13	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49358-601-01	49358060101	1 APPLICATOR in 1 CARTON (49358-601-01) / 4.2 g in 1 APPLICATOR	1 applicator	2023-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen	MDSolarSciences	2025-06-05	HUMAN OTC DRUG LABEL	2