ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50

Product NDC: 42851-092
11-digit product format: 428510092
Labeler code: 42851
Product ID: 42851-092_44883680-7c35-a55f-e063-6394a90aaa42
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, Octocrylene
Dosage form: GEL
Route: TOPICAL
Labeler: ZO Skin Health, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-30
Substance: OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength: 4.5; 1.35; 2.25 g/45g; g/45g; g/45g
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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42851-092-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42851-092-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42851-092-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42851-092-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42851-092-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42851-092-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42851-092-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42851-092-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42851-092-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42851-092-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42851-092-45	`367a005e9d99…`	`383a685ebd0f…`

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: ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	4.5 g/45g
AVOBENZONE	1.35 g/45g
OCTISALATE	2.25 g/45g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	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
ec8386f2-9cb7-40f4-e053-2995a90ac2d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42851-092-34	ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50	1 in 1 CARTON	GEL	1		4
42851-092-34	ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50	96 g in 1 TUBE	GEL	96		4

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 47 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4a822-a7ab-b374-e063-6394a90a8508	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4d44e-3421-535f-e063-6294a90a2fea	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef5baf7-00b1-97aa-e063-6294a90aab9c	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef5dcd4-b2d0-bcd1-e063-6294a90a871f	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef669b9-df00-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef6a60a-6634-e79b-e063-6394a90a3daa	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef6b5fb-5495-001c-e063-6394a90ab7b3	2026-04-08	Warnings	Exact identifier application number: M020
Sunright Lip Balm	OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc.	dfdb2d0a-c646-4c44-b648-e2fdd604cdc9	2026-04-08	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light Golden	TITANIUM DIOXIDE	NSE Products, Inc.	faae6f47-19f3-41cb-8e0d-388569b5c73d	2026-04-07	Warnings	Exact identifier application number: M020
Ultra Sunscreen	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	Jiangsu Senwo Medical Technology Co., Ltd.	4ed974b8-6c11-08e0-e063-6294a90a7713	2026-04-07	Warnings	Exact identifier application number: M020
Vivaiodays SPF 30 Sunscreen with Turmeric	SPF 30 SUNSCREEN WITH TURMERIC	5SENCO INC	4ee0c93a-7f50-2bda-e063-6294a90abff4	2026-04-07	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc	4ee39bbf-b7d7-8f87-e063-6294a90a2539	2026-04-07	Warnings	Exact identifier application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREEN	ZINC OXIDE	Beverly Hills MD, LLC	4ed34743-cc68-501b-e063-6294a90ad396	2026-04-07	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB plus Foundation - Beige	TITANIUM DIOXIDE	NSE Products, Inc.	f74e83fe-41a0-4998-ae53-30ed5af47592	2026-04-07	Warnings	Exact identifier application number: M020
Thinksport SPF 30	ZINC OXIDE	thinkOperations,LLC	33065919-9b4e-4b2b-9306-a706558241c8	2026-04-07	Warnings	Exact identifier application number: M020
Nutricentials Day Dream Protective	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc	daca8347-f7e7-4733-bd22-1da7a6076fad	2026-04-06	Warnings	Exact identifier application number: M020
TONEfitSUN Ultra Moisturizing Vegan Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory	4ec58c23-16b1-03bb-e063-6394a90a46c0	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15	HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	be36b83f-662d-49c6-a12f-a64e11721d0c	2026-04-06	Warnings	Exact identifier application number: M020
Pure Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Liz Corporation Ltd	4eca5257-6840-2a33-e063-6394a90ade28	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	4a5147f3-4e52-447a-a89c-058aea8a612c	2026-04-06	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42851-092-34	42851009234	1 TUBE in 1 CARTON (42851-092-34) / 96 g in 1 TUBE	1 tube	2025-10-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50	ZO Skin Health, Inc.	2025-11-26	HUMAN OTC DRUG LABEL	4