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
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	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 166 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8acb660f-94bd-4c4f-b0c1-3682cf8ed543	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	fad2bec7-c5f4-45f4-aff4-a5022033cb6a	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	39856c69-84fb-4b12-a713-8912263e42b1	2025-11-07	Warnings	Exact identifier application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	287aa255-4601-c5be-e063-6394a90a4d74	2025-11-07	Warnings	Exact identifier application number: M020
e l f Holy Hydration Face SPF 30 Sunscreen,	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	44a8028b-731d-4561-b2e3-ee9738ad8d30	2025-11-07	Warnings	Exact identifier application number: M020
e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve	ZINC OXIDE	e.l.f. Cosmetics, Inc.	bce21361-c92c-40ad-a373-db3b83b15b8a	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer Sunburst	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	49d912c7-259a-487d-a523-b14031bfaab6	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer Sunlight	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d	2025-11-07	Warnings	Exact identifier application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	f818f524-0263-4f89-b4f3-4dd83d688e7e	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Invisible Sunscreen SPF 35	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	e.l.f. Cosmetics, Inc	c2af5591-04df-4958-901e-dbe11698b844	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much	ZINC OXIDE	e.l.f. Cosmetics, Inc.	53d64042-f9ef-494d-a347-490c6a3c49b8	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f cosmetics,Inc.	547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d	2025-11-07	Warnings	Exact identifier application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam	ZINC OXIDE	e.l.f. Cosmetics, Inc.	b7d56015-4734-4ce4-b40d-64236df810e3	2025-11-07	Warnings	Exact identifier application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween	ZINC OXIDE	e.l.f. Cosmetics, Inc.	4d9784b6-c54d-483d-a5ba-c557a05300ec	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOW	ZINC OXIDE	In The Pynk LLC	13badac4-e310-9589-e063-6394a90ab06b	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOUR	ZINC OXIDE	In The Pynk LLC	13bb8426-27cd-fbc9-e063-6294a90a8bf8	2025-11-07	Warnings	Exact identifier application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOU	ZINC OXIDE	In The Pynk LLC	1365c6d8-64cb-3cb3-e063-6394a90a9d64	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 10w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a935e6-f7ac-4e3a-e053-2a95a90a877a	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 11w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a94fb4-8752-587c-e053-2995a90a1e9a	2025-11-07	Warnings	Exact identifier application number: M020
Well People Bio Tint SPF 30 Sunscreen 13w	ZINC OXIDE	e.l.f. Cosmetics, Inc	c8a9bf6c-80cd-5884-e053-2a95a90a4a66	2025-11-07	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