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 66 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zealios Mineral SPF 30 Sunscreen	ZINC OXIDE	Personal Best Products Inc. dba Zealios	c421b00c-6536-4455-81f6-01686f8c2388	2026-02-03	Warnings	Exact identifier application number: M020
Zealios Sport Performance Ultralight SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Personal Best Products Inc. dba Zealios	020bd1b4-da50-4117-a4f3-b74aa4187396	2026-02-03	Warnings	Exact identifier application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Color Me Beautiful Inc	f65e1428-b79a-4126-862a-907ca17ee8f7	2026-02-02	Warnings	Exact identifier application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Color Me Beautiful Inc	934d6b80-0cc3-4dcd-a25d-2191bd273618	2026-02-02	Warnings	Exact identifier application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOW	HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%	S&C Hampton Sun LLC	26190992-9463-47ae-86a5-0dbc05be8773	2026-02-02	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Rite Aid Corporation	fe9146ec-b85d-43da-a391-377960f2c772	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	299a6690-9746-4410-a625-7636f0b4a754	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
Dr. C. Tuna Sun Stick SPF 50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Farmasi US LLC	49dc6040-b400-7f5b-e063-6394a90ac7d7	2026-02-02	Warnings	Exact identifier application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50	ZINC OXIDE	e.l.f. Cosmetics, Inc	535f798f-d21d-92b2-e063-6294a90a72c7	2026-02-02	Warnings	Exact identifier application number: M020
Sol de Janiero Rio Radiance SPF 50 Body	ZINC OXIDE	Cosmetic Solutions LLC	2d54727d-5dcc-4792-85e8-1a2f21fe9e3d	2026-02-02	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 50	ZINC OXIDE	Delta Ecommerce LLC	47d9dc66-328f-4cab-e063-6394a90a279d	2026-02-01	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f cosmetics,Inc.	4b801bb3-8930-7e04-e063-6294a90adaa1	2026-02-01	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEAR	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	cedd7a3e-3334-437f-a283-482bcd0064ee	2026-01-30	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	bf16e8b5-b717-4255-a7da-9abe3d1ad8b4	2026-01-30	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	372a8fba-b190-40fe-a1fc-fecf7f7afc35	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M020
ALOE UP MEDICATED LIP BALM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	859b6d3f-b1ca-4966-8f0c-f9afa0d5864c	2026-01-30	Warnings	Exact identifier application number: M020
ALOE UP SPORT NATURAL BALM SPF-15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	3de029ed-97f7-4cb3-a32e-d412bf3b5874	2026-01-30	Warnings	Exact identifier application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	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