Hydrating Sheer Lip Balm SPF 30 - SHIMMER

Product NDC: 49358-604
11-digit product format: 493580604
Labeler code: 49358
Product ID: 49358-604_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	49358-604-01	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	49358-604-01	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	49358-604-01	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	49358-604-01	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	49358-604-01	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	49358-604-01	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	49358-604-01	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 - SHIMMER
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
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	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
49358-604-01	2025-06-05	C162847	48780-1	2cef2736-5aef-d83d-e063-dadaa90ab31f	Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen
49358-604-01	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
49358-604-01	Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen	1 in 1 CARTON	LIPSTICK	1		2
49358-604-01	Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad 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
49358-604	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 202 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	Warnings	Exact identifier application number: M020
78 x 36 SPF 30 Active	ZINC OXIDE	Dermazone LLC	96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	2025-07-25	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 30 Active	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	5ec1510d-1465-4849-9e23-f16e11ff0e65	2025-07-25	Warnings	Exact identifier application number: M020
Skinuva Scar plus	ZINC OXIDE	MD Medical Designs, Inc.	5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 29 Active with DNArescue	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	99fb90ca-6527-459b-8af2-627ea9abe11b	2025-07-25	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa93f52-ec01-01c2-e063-6294a90a9347	2025-07-24	Warnings	Exact identifier application number: M020
Mineral Suscreen SPF 30	ZINC OXIDE 19.0%	Vivant Pharmaceuticals, LLC	3aadb658-d12d-ae8d-e063-6394a90a6496	2025-07-24	Warnings	Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier application number: M020
Leg and Body Makeup Broad Spectrum SPF 25	OCTISALATE 3.2% OCTOCRYLENE 6%	Baxter of California, LLC	14adc826-6e9d-382a-e063-6294a90a5d79	2025-07-24	Warnings	Exact identifier application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20	AVOBENZENE, OCTINOXATE, OCTOCRYLENE	TIEGE HANLEY, Inc	22086cd8-2126-120e-e063-6394a90a561e	2025-07-24	Warnings	Exact identifier application number: M020
Tulip Dew SHIELD GLOW	ZINC OXIDE	Bloomeffects, Inc.	150f9660-48ec-a189-e063-6294a90a6d49	2025-07-23	Warnings	Exact identifier application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Pelotan LLC	3a9f94eb-98b7-5a20-e063-6394a90a173b	2025-07-23	Warnings	Exact identifier application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a9fc050-f74f-a431-e063-6294a90ad4c2	2025-07-23	Warnings	Exact identifier application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Pelotan LLC	3aa0799b-0790-2476-e063-6294a90a8bcc	2025-07-23	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa3c442-26a6-0ab0-e063-6294a90a93a5	2025-07-23	Warnings	Exact identifier application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a89106d-dbf0-e6ea-e063-6294a90a60f3	2025-07-22	Warnings	Exact identifier application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a898964-b4aa-e86d-e063-6394a90a34c6	2025-07-22	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal System Kit	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3512c120-b8ba-ba59-e063-6394a90ac1e2	2025-07-22	Warnings	Exact identifier application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a89d736-efef-088e-e063-6394a90a5e62	2025-07-22	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
49358-604-01	49358060401	1 APPLICATOR in 1 CARTON (49358-604-01) / 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