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 68 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Centellian24 Madeca Derma Shield Vital Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e11009-ffcb-dd59-e063-6294a90add22	2026-01-27	Warnings	Exact identifier application number: M020
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M020
ONSART Mineral Sunscreen SPF 50	ZINC OXIDE 24%	Guangzhou Huixue Biotechnology Co., Ltd.	495e3266-a59f-42f7-e063-6394a90adfa3	2026-01-27	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	54868d6f-ae4c-476d-8c77-c4a72b13d2ea	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	dd036e0c-0c27-42b3-9d2c-33839a8631f9	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink Ice	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ea23616f-1d59-4e32-88bb-d035af727728	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic Twist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	21b6239b-26d0-4b6b-8aee-fe1f20d8aaea	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla Icing	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	483b6873-fe58-4a38-bf82-df116617c5f0	2026-01-27	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50 MINERAL	S&C Hampton Sun	4960930e-a1bf-d850-e063-6294a90a4084	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier application number: M020
Golden Glow SHIMMER MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	4963e513-d1fc-4b0e-e063-6394a90a7ddf	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO	LE COSMETICS INC	49643a56-3627-67f8-e063-6294a90a2d7b	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS	LE COSMETICS INC	49644002-153e-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	496ba4c4-6577-88ff-e063-6294a90a0995	2026-01-27	Warnings	Exact identifier application number: M020
Vacation Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	b442530f-cae3-418b-9675-c18879653826	2026-01-27	Warnings	Exact identifier application number: M020
EltaMD UV Clear Blemish-Prone and Oil Balancing	OCTINOXATE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6337b9e3-2524-4292-8fc8-1f6aad6cfe05	2026-01-27	Warnings	Exact identifier application number: M020
SPF Ginger Sunscreen SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SPF GINGER LLC	f303ad78-5fa3-40d1-9b1c-53ae1ca73aed	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	8506049f-cb43-4d1d-885b-c6d3a99bbba3	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	144178e7-2df9-49c3-9667-43986cee89c4	2026-01-26	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
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