ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Product NDC: 42851-055
11-digit product format: 428510055
Labeler code: 42851
Product ID: 42851-055_25df0034-2b20-a2af-e063-6394a90affe7
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: ZO Skin Health, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-01
Marketing end: 2026-11-01
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
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 · 9 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42851-055-45	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42851-055-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42851-055-45	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42851-055-17	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42851-055-45	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42851-055-17	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Additional Listing Data#

Finished product: Yes
Brand name base: ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	30 mg/mL
AVOBENZONE	100 mg/mL
HOMOSALATE	50 mg/mL
OCTISALATE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	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
cda67d41-d063-4936-a6b9-23376304eb42	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
42851-055-17	2021-02-11	ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-45	2021-02-11	ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-17	2020-01-31	ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-45	2020-01-31	ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42851-055-20	ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	20 mL in 1 TUBE	LOTION	20	6
42851-055-20	ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	1 in 1 CARTON	LOTION	1	6
42851-055-45	ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	45 mL in 1 TUBE	LOTION	45	6
42851-055-45	ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	1 in 1 CARTON	LOTION	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42851-055	ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20241107_cda67d41-d063-4936-a6b9-23376304eb42.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 1 of 361 · 7,202 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN	ZINC OXIDE	ISNTREE Inc.	58e38665-0bca-fb02-e063-6394a90ad62a	2026-08-13	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d3d390-8b88-a6fe-e063-6394a90a9bf8	2026-08-12	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d7a3e3-b7df-43ce-e063-6294a90a729c	2026-08-12	Warnings	Exact identifier application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50	ZINC OXIDE	CP Skin Health Group, Inc	58dd81db-46d4-d763-e063-6394a90abb0b	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50 Red Correcting	ZINC OXIDE	CP Skin Health Group, Inc.	26e63890-d1af-d171-e063-6394a90af828	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50	ZINC OXIDE	CP Skin Health Group, Inc.	26d2683f-cfd5-50fd-e063-6394a90a7576	2026-08-12	Warnings	Exact identifier application number: M020
doTERRA Sun Body	MINERAL SUNSCREEN	doTERRA International, LLC	58dcc56f-f093-469c-e063-6394a90a6088	2026-08-12	Warnings	Exact identifier application number: M020
Colorescience Total Protection Body Shield Glow	ZINC OXIDE	Colorescience	52e1d987-a4f8-195e-e063-6294a90a5629	2026-08-11	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DR. SAMRAO'S OFFICE	58b2ca35-11ed-d848-e063-6294a90a5b37	2026-08-11	Warnings	Exact identifier application number: M020
Ciele Tint and Protect	ZINC OXIDE	Ciele	0162d9c9-07fa-9210-e063-6294a90aa687	2026-08-11	Warnings	Exact identifier application number: M020
NeoStrata Skin Active Matrix Support SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	8e4b9c08-b906-4c5f-a243-55838ae28b90	2026-08-10	Warnings	Exact identifier application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-10	Warnings	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	1c7cd904-ffff-48aa-91bd-cc978946b36a	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	22aa46af-5d0f-4256-8f45-be06f6627561	2026-08-10	Warnings	Exact identifier application number: M020
Colorescience Total Protection No Show Mineral Body Shield	ZINC OXIDE	Colorescience	52e1f59e-63cb-7480-e063-6394a90ad7c5	2026-08-10	Warnings	Exact identifier application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Merz North America, Inc.	d4d4bfcf-3674-4847-8ad8-1716a8e821ae	2026-08-10	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen	BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE	Grace and Fire USA Inc.	56ad0dce-410e-9d78-e063-6294a90a1c3e	2026-08-09	Warnings	Exact identifier application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen	ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Guangzhou Yapheon Health Industry Co., Ltd.	552a36ed-7a66-4048-e063-6394a90a09bc	2026-08-08	Warnings	Exact identifier application number: M020
lip balm SPF15( 2533) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5870aa44-1375-cdc5-e063-6394a90af4a5	2026-08-07	Warnings	Exact identifier application number: M020
lip balm SPF15( Zinc oxide) 01	ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5871ab1d-cf07-d737-e063-6394a90a58fe	2026-08-07	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
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42851-055-20	42851005520	1 TUBE in 1 CARTON (42851-055-20) / 20 mL in 1 TUBE	1 tube	2022-06-01	2026-11-01	No	No	Current
42851-055-45	42851005545	1 TUBE in 1 CARTON (42851-055-45) / 45 mL in 1 TUBE	1 tube	2022-06-01	2026-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	ZO Skin Health, Inc.	2024-11-01	HUMAN OTC DRUG LABEL	6