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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sky and Sol Face and Body Sunscreen SPF 50	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	473a6ade-1f0a-c711-e063-6294a90a2b83	2026-03-30	Warnings	Exact identifier application number: M020
Vacation by Vacation Scent and Shimmer Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	0c4e6fa1-c78d-4f9d-969f-135d4ed67daf	2026-03-30	Warnings	Exact identifier application number: M020
Marie originals - ProActive Sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4e3204bf-eda4-2bdf-e063-6394a90ae429	2026-03-29	Warnings	Exact identifier application number: M020
Sport Ultra	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	37c5dcf7-dc2d-624f-e063-6394a90ae992	2026-03-29	Warnings	Exact identifier application number: M020
ULTRALIGHT AGE DEFENSE SPF 50	ZINC OXIDE	Guangzhou Origin Beauty Cosmetics Co., Ltd.	4e36a743-7906-2b7b-e063-6294a90af314	2026-03-29	Warnings	Exact identifier application number: M020
Stay Put Sunscreen SPF 30	OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%	Sawyer Products Inc	7ecba495-a912-4697-8287-2e5836e610e1	2026-03-27	Warnings	Exact identifier application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	4e0bd355-99c6-8cf4-e063-6294a90ab4b3	2026-03-27	Warnings	Exact identifier application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	61c48acc-f589-40d3-b289-b777db5551db	2026-03-27	Warnings	Exact identifier application number: M020
Truly Solar Baby Suncreen SPF 45	HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%	Truly Beauty, Inc	38e6c6fc-d8b9-4196-96c7-0f6d5d06da02	2026-03-26	Warnings	Exact identifier application number: M020
burnd	HOMOSALATE, OCTINOXATE, ZINC OXIDE	BURND LLC	31cf923e-fdde-790b-e063-6294a90a60ee	2026-03-26	Warnings	Exact identifier application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Classic Cosmetics LLC	4df3b8c0-71bc-acdd-e063-6394a90a35c0	2026-03-26	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	4df77564-9da0-7e48-e063-6294a90a5e6b	2026-03-26	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	3804a14b-be7c-a973-e063-6294a90ac7fc	2026-03-25	Warnings	Exact identifier application number: M020
Softlips Oasis Pineapple Coconut	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	c504463a-28bf-4161-875f-ef73520931c5	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Cherry, SPF 15 Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37f2c3a6-7790-c8ec-e063-6294a90ace22	2026-03-25	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice - Original, SPF 15 Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	37dc44aa-17b2-8721-e063-6294a90a34f6	2026-03-25	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	0ef5d5ce-3bdf-dffc-e063-6394a90aad54	2026-03-25	Warnings	Exact identifier application number: M020
Silkscreen Sheer Tint Mineral Light-Medium	TITANIUM DIOXIDE, ZINC OXIDE	Curology	4ddbe349-6880-a5fc-e063-6294a90a275c	2026-03-25	Warnings	Exact identifier application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3	ZINC OXIDE	Asia Master Trade Co.,Ltd	1f310fb1-185a-b467-e063-6294a90a72fe	2026-03-25	Warnings	Exact identifier application number: M020
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4e0450ca-147a-91d7-e063-6394a90ae73b	2026-03-25	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