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: OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength: 100; 30; 100; 50 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…`

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 Smart Tone Broad-Spectrum Sunscreen SPF 50

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	100 mg/mL
AVOBENZONE	30 mg/mL
HOMOSALATE	100 mg/mL
OCTISALATE	50 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 44 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRUST MD SPF30 STEM CELL FACE	OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE	Guangzhou Yapheon Health Industry Co., Ltd.	4f2ca12c-bc6f-61b8-e063-6294a90a0d7e	2026-04-11	Warnings	Exact identifier application number: M020
MIDHA Rice Daily Moisture Sun Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MIDHA Cosmetic Co.,Ltd.	4b394107-7830-c2c6-e063-6294a90a07d9	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Deep	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f15d5ba-6396-56bf-e063-6394a90adb06	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Light	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f165895-aa84-e215-e063-6394a90a6256	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Medium	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f16b8a4-4279-5f79-e063-6294a90a353d	2026-04-10	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	f5ca0416-548c-4be0-a69e-c7e1b52aba95	2026-04-10	Warnings, Adverse reactions	Exact identifier application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT	ZINC OXIDE	The Green Cricket Inc	c56fd135-f46a-51ce-e053-2a95a90ab7b3	2026-04-10	Warnings	Exact identifier application number: M020
CorTex SunX 50 Thick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	f67a6c6c-c314-1c9d-e053-2a95a90a7f1a	2026-04-10	Warnings	Exact identifier application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18	OCTINOXATE AND ZINC OXIDE	NSE Products, Inc.	b9635e59-bb08-4167-b7ba-54c3fc712589	2026-04-09	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	79c6fe2a-34c2-44cc-81bc-796c4463d2a6	2026-04-09	Warnings, Adverse reactions	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdbae5-84ec-7b1d-e063-6294a90a2878	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15	SUNSCREEN LIP BALM	Arizona Sun Products	11e9cb25-6ff8-a121-e063-6394a90a849e	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 8	SUNSCREEN	Arizona Sun Products	11e8b612-29be-47ed-e063-6394a90ab9e7	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdcfd0-8b24-7efc-e063-6294a90af7fa	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Cycleblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e71a84-12d1-2d4f-e063-6294a90adcd6	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Bikerblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e6eafd-f967-b748-e063-6394a90aabfd	2026-04-09	Warnings	Exact identifier application number: M020
YSE Beauty Skin Glow Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MSS Beauty LLC	6a318e27-14e5-488e-ac19-010f69cb743d	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30	SUNSCREEN	Arizona Sun Products	116ed17c-3b38-5e96-e063-6294a90a4246	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Surfblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e76815-9316-555d-e063-6294a90aeb81	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Moisturizer SPF 3	MOISTURIZER	Arizona Sun Products	1171af26-3040-552c-e063-6294a90ae220	2026-04-09	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
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

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