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
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
49358-604-01	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 160 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c6252f-56b8-9e3c-e063-6294a90aa12c	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c62e80-9ace-c1f2-e063-6294a90a5bfa	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c6864c-bc8e-e900-e063-6294a90a7a14	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c77b48-18fb-3efe-e063-6294a90ade4b	2025-11-17	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	43c784ce-3a54-5416-e063-6294a90ac9a2	2025-11-17	Warnings	Exact identifier application number: M020
Daily Essential Face Moisturizer	ZINC OXIDE	Solarium Brands LLC	2a92edc1-04ac-3eda-e063-6294a90ad46d	2025-11-17	Warnings	Exact identifier application number: M020
Daily Essential Eye Cream	TITANIUM DIOXIDE, ZINC OXIDE	Solarium Brands LLC	2a931d9f-4ba8-e3a5-e063-6294a90af780	2025-11-17	Warnings	Exact identifier application number: M020
Daily Essential Lip Oil Blushing Nude	ZINC OXIDE	Solarium Brands LLC	2a93998c-185b-9207-e063-6294a90ab0e9	2025-11-17	Warnings	Exact identifier application number: M020
Solarium Daily Essentials Skin Perfecting Primer	ZINC OXIDE	Solarium Brands LLC	302a02d1-3dc5-2745-e063-6394a90ab6d2	2025-11-17	Warnings	Exact identifier application number: M020
Solarium Daily Essentials Luminizing Glow Drops	ZINC OXIDE	Solarium Brands LLC	302a4efe-d429-b1c4-e063-6294a90a073d	2025-11-17	Warnings	Exact identifier application number: M020
Daily Essential Lip Oil Dusty Rose	ZINC OXIDE	Solarium Brands LLC	2a934860-02a7-a463-e063-6294a90aa446	2025-11-17	Warnings	Exact identifier application number: M020
Daily Essential Lip Oil Scarlet Bloom	ZINC OXIDE	Solarium Brands LLC	2a931e78-e58c-e216-e063-6294a90a3e49	2025-11-17	Warnings	Exact identifier application number: M020
Morning Person Daily Repair Protect Moisturizer	ZINC OXIDE	Morning Person Beauty	33a20264-9216-154e-e063-6294a90a3c8b	2025-11-17	Warnings	Exact identifier application number: M020
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS	HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE	Edgewell Personal Care Brands LLC	c780d5cf-8388-42e0-e053-2a95a90a7c04	2025-11-17	Warnings	Exact identifier application number: M020
Hell on Earth The Resistance Daily Face Moisturizer	TITANIUM DIOXIDE, ZINC OXIDE	Hell on Earth	38debebf-1e12-09f3-e063-6294a90a9a2a	2025-11-17	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	e64de59e-b8db-522e-e053-2a95a90ac458	2025-11-17	Warnings	Exact identifier application number: M020
Credo Skin Solar Limits Serum	ZINC OXIDE	Eco-Chic LLC	395dc8eb-978b-a18f-e063-6294a90a2207	2025-11-17	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	05ce5223-3fb2-4c27-e063-6394a90a8a8f	2025-11-17	Warnings	Exact identifier application number: M020
Credo Follain Daily Mineral Sunscreen	ZINC OXIDE	Eco-Chic LLC	395d6ad4-04ae-8945-e063-6294a90ad87c	2025-11-17	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	0c7b7571-7317-98bc-e063-6294a90aa29f	2025-11-17	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