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 58 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2000DL-CL30T	SPF30 BS TROPICAL	Epic Laboratories, LLC	0286f94e-a2e8-b529-e063-6294a90ac08d	2026-03-02	Warnings	Exact identifier application number: M020
2000DL-CL30V	SPF30 BS ORIGINAL	Epic Laboratories, LLC	1872eefd-d702-ac9f-e063-6294a90a24ef	2026-03-02	Warnings	Exact identifier application number: M020
JAYSUING White Birch Moisturizing Sunscreen Cream	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	4c174691-cc32-b2e4-e063-6294a90a0f73	2026-03-02	Warnings	Exact identifier application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer	ZINC OXIDE	Kypris Beauty LLC	a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3	2026-02-27	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Chain Drug Marketing Association	6307627a-94e2-47ea-8519-68975716dd6e	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVEBONZONE, HOMOSALATE, OCTISALATE	Chain Drug Marketing Association	a38e150e-2e50-4936-ae46-408f9cf82d15	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Chain Drug Marketing Association	87811c86-19d2-4179-8d22-2aeb4680ff57	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVEBONZONE, HOMOSALATE, OCTISALATE	Chain Drug Marketing Association	d7215a32-00a9-4b70-8597-8ea91f546c1e	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVEBONZONE, HOMOSALATE, OCTISALATE	Chain Drug Marketing Association	9fccccd4-2d2e-4812-85b1-bbeb44ff04ea	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	be702a3b-1652-4468-803d-295100d3e3e2	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	644ec129-15c9-4ac1-8362-5b4c2e58ab9a	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
SPF Beauty	SPF BEAUTY	Walmart Inc.	f06f26af-81d6-4603-b377-fd12430ec952	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
SPF Moisturizer	SPF MOISTURIZER	Walmart Inc.	41de3171-9ed3-45da-96fb-dfcf41912229	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Facial Moisturizer	DAILY FACIAL MOISTURIZER SPF 15	Walmart Inc.	2cec9c90-2e64-f005-e063-6294a90a8753	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Walmart Inc.	309d881d-40e0-37bc-e063-6294a90a3769	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M020
Avbenzone, Homosalate, Octisalate	AVBENZONE, HOMOSALATE, OCTISALATE	Walmart Inc.	d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a	2026-02-27	Warnings	Exact identifier application number: M020
MELAO Sunscreen Stick	ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONE	Guangdong Aimu Biological Technology Co., Ltd	4ba15c03-0409-918b-e063-6294a90ac6ee	2026-02-26	Warnings	Exact identifier application number: M020
TIBENA EVERY DAY REAL SUN BLOCK	TITANIUM DIOXIDE, ZINC OXIDE	KONAD CO LTD	211c9930-4f91-cf8f-e063-6394a90a97b3	2026-02-26	Warnings	Exact identifier application number: M020
Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	4bbc0639-3a80-1c28-e063-6394a90a3c00	2026-02-26	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10	TITANIUM DIOXIDE	Shiseido Americas Corporation	54f8210f-4934-4ada-89c3-aa89e7a09260	2026-02-26	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