Gleam plus Glow SPF 50.

Product NDC: 49358-581
11-digit product format: 493580581
Labeler code: 49358
Product ID: 49358-581_36d8c259-4314-0d27-e063-6294a90ae57a
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, and Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 30; 50; 27.5 mg/mL; mg/mL; mg/mL
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	49358-581-01	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	49358-581-01	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	49358-581-01	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	49358-581-01	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	49358-581-01	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	49358-581-01	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	49358-581-01	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: Gleam plus Glow SPF 50.
Brand name suffix: SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	30 mg/mL
OCTISALATE	50 mg/mL
OCTOCRYLENE	27.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
3e392af6-1401-4a2f-9ba4-e43f0fd0fca1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49358-581-01	2025-06-05	C162847	48780-1	2cef2736-6f97-d83d-e063-dadaa90ab31f	Gleam + Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint
49358-581-01	2025-01-30	C162847	48780-1	2cef2736-6f97-d83d-e063-dadaa90ab31f	Gleam + Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-581-01	Gleam plus Glow SPF 50.SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint	50 mL in 1 BOTTLE, PUMP	LOTION	50		2
49358-581-01	Gleam plus Glow SPF 50.SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint	1 in 1 CARTON	LOTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-581	GLEAM PLUS GLOW SPF 50. SPF 50 BROAD SPECTRUM SUNSCREEN UVA-UVB SHEER GLOW TINT (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230920_3e392af6-1401-4a2f-9ba4-e43f0fd0fca1.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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tanning Club Mineral Sunscreen SPF 30	ZINC OXIDE	Tanning Club LLC	d674ccbc-7bae-435c-a531-a79e569e69a9	2026-02-04	Warnings	Exact identifier application number: M020
Derma B Everyday Fit Sunscreen SPF 50	AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NeoPharm Co., Ltd.	ba38a43d-7a8a-4814-ba34-0e99124f5fca	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	86630e82-f249-4866-82dd-3e21feb266c4	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	42adc51f-f500-485d-82a0-126672141262	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	60e55ebb-47b8-465e-819a-af195952e1ca	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f644c67b-3a71-411b-b321-39a8b18af0c7	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE N	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	4b242b76-8aed-4939-9906-741828acd815	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	efcf240f-95cb-45e0-b58a-9c8f3609aa55	2026-02-04	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	270ecc83-4262-4102-a753-2acaf11360a0	2026-02-04	Warnings	Exact identifier application number: M020
Walgreens 50 Caramel and Pistachio Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	4a038017-9f15-b4b2-e063-6294a90a1b23	2026-02-04	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Shiseido Americas Corporation	ce6a28c1-56e6-4105-bc9d-9d1986ead420	2026-02-04	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	d52e2c61-edbc-4c26-b1a7-e8eb656db188	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	d365ed6d-a92f-473b-be19-b8b63d17f3b7	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	0a3b4597-06fe-4689-9751-6577867d755e	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	HARRIS TEETER	b83ea476-fa32-4405-9ae3-f294836edb62	2026-02-04	Warnings	Exact identifier application number: M020
Sunplus SPF50 Face Body Sunscreen	SUNSCREEN	I.Shay Cosmetics	26d55baf-66dc-b1b8-e063-6394a90a670d	2026-02-04	Warnings	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	351217c4-8d71-41d9-ab08-c43857c0510c	2026-02-04	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sun Stick	SUN STICK	Proso Corp	49eca4f2-aae3-a0d5-e063-6394a90ab25f	2026-02-03	Warnings	Exact identifier application number: M020
Shiny Hiny SPF 45 Mineral Sunscreen	ZINC OXIDE	Shiny Hiny Products, LLC	31adde36-5e1b-40ff-e063-6294a90a6f2e	2026-02-03	Warnings	Exact identifier application number: M020
Walgreens 50 Passion Fruit Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	49f030d8-959c-a3cd-e063-6294a90ae1ba	2026-02-03	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
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
49358-581-01	49358058101	1 BOTTLE, PUMP in 1 CARTON (49358-581-01) / 50 mL in 1 BOTTLE, PUMP	2023-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gleam + Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint	MDSolarSciences	2025-06-05	HUMAN OTC DRUG LABEL	2