Hydrating Sheer Lip Balm SPF 30 -Crystal

Product NDC: 49358-600
11-digit product format: 493580600
Labeler code: 49358
Product ID: 49358-600_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	49358-600-01	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	49358-600-01	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	49358-600-01	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	49358-600-01	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	49358-600-01	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	49358-600-01	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	49358-600-01	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 -Crystal
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
49358-600-01	2025-06-05	C162847	48780-1	2cef2736-5aef-d83d-e063-dadaa90ab31f	Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen
49358-600-01	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
49358-600-01	Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen	4.2 g in 1 APPLICATOR	LIPSTICK	4.2		2
49358-600-01	Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen	1 in 1 CARTON	LIPSTICK	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-600	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 54 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	4ce63abb-e716-40de-e063-6394a90a6e76	2026-03-15	Warnings	Exact identifier application number: M020
GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CLIO COSMETICS Co., Ltd.	8d147089-709f-4468-a47d-9251e737c9a4	2026-03-15	Warnings	Exact identifier application number: M020
Cay Skin Isle Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Cay Skin, Inc.	d92a17c4-9827-5fb1-e053-2a95a90a9ca1	2026-03-13	Warnings	Exact identifier application number: M020
DAILY FACE SUNSCREEN Broad Spectrum SPF 30	ZINC OXIDE	Lilyana Naturals LLC	e5f53e2f-6566-4eac-b9b5-7697abaf044b	2026-03-13	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	af052521-bfa6-4142-a10b-ef51f474a077	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	42647444-93a3-4d2c-9bfc-91621fd098f7	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Babies SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	a4b9d7c0-dc09-4f0e-8b65-90ba180552bf	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
TINTED WATERY SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	KSISTERS PTE. LTD.	4ced53d0-8bfc-ff8e-e063-6294a90a9dbd	2026-03-13	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Mother s Day Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4cf03092-7886-ffa1-e063-6294a90a2aad	2026-03-13	Warnings	Exact identifier application number: M020
Daily Moisturizing Mineral Sunscreen	BROAD SPECTRUM SPF30	EDINA PLASTIC SURGERY,LTD.	4d056e2b-5813-da42-e063-6294a90ac519	2026-03-13	Warnings	Exact identifier application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra light	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	L'Oreal USA, Inc.	dad00eee-92cd-7610-e053-2a95a90a1fac	2026-03-13	Warnings	Exact identifier application number: M020
VITARAN REJUVENA SUNCARE	ALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATE	BR PHARM CO. , Ltd.	4cb7af72-49f6-0738-e063-6394a90a79eb	2026-03-12	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4cd0a8a7-11aa-e168-e063-6394a90a2ff2	2026-03-12	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Vi-Jon, LLC	3da4706e-7c1a-435e-9603-e9aa98432018	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	53806657-7b4d-45ff-a75b-9340dcd8140e	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	08237b4c-4e5c-4b12-9510-2f8d64ab7f3a	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 Fairfax	ZINC OXIDE	Tower 28	108851ac-3812-4c02-a04a-9f9a7f529ed6	2026-03-12	Warnings	Exact identifier application number: M020
DIY Booster SPF 30 Facial Serum Unscented	OCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDE	Andalou naturals	ebaf5ef7-84aa-4cb1-a701-2e0d0fd357df	2026-03-12	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation INC.	f268fb1c-d7c2-f2f9-e053-2995a90a9e22	2026-03-12	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C	TITANIUM DIOXIDE	Kenvue Brands LLC	4c335d9c-40ca-c0ce-e063-6394a90ac20a	2026-03-11	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
49358-600-01	49358060001	1 APPLICATOR in 1 CARTON (49358-600-01) / 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