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 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Natural Ice Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	29220eaa-87cb-4ebe-87db-d36288b3a9e4	2026-03-24	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	f54c617f-794e-413b-b898-4a06622b4bee	2026-03-24	Warnings, Adverse reactions	Exact identifier application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Shiseido Americas Corporation	7b2d15c1-b9e1-4347-b138-9883f78822b3	2026-03-24	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd05620-30a3-9cea-e063-6294a90af18b	2026-03-24	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd1b722-4448-9675-e063-6294a90a5f4f	2026-03-24	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen SPF30	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	2dda185c-6ff8-953d-e063-6394a90acc53	2026-03-24	Warnings	Exact identifier application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN	ZINC OXIDE	ENS KOREA Co., Ltd.	34f9688d-efa1-1d3f-e063-6294a90ab127	2026-03-23	Warnings	Exact identifier application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50	SUN SCREEN	Guangdong Bisutang Biotechnology Co., LTD	4dade579-ce77-eea5-e063-6394a90ad46a	2026-03-23	Warnings	Exact identifier application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVE	ZINC OXIDE	TIRTIR USA Inc.	4c92db00-59f1-ac02-e063-6394a90a7cf1	2026-03-23	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50	The Soleil Group, LLC	27d20573-0b6b-4d4b-94ca-69b476a883a7	2026-03-23	Warnings	Exact identifier application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30	ZINC OXIDE	Babo Botanicals, Inc.	4db37efb-2d37-7428-e063-6394a90a10e4	2026-03-23	Warnings	Exact identifier application number: M020
All Good Mineral Sport Sunscreen Butter	ZINC OXIDE	Elemental Herbs, Inc.	ff334e9c-dd12-92bc-e053-6394a90aa24b	2026-03-23	Warnings	Exact identifier application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50	ZINC OXIDE	Elemental Herbs, Inc.	fe2bf779-e8b3-933f-e053-6394a90a369f	2026-03-23	Warnings	Exact identifier application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	skinnplus	4dbc1035-c41c-308c-e063-6394a90a36c4	2026-03-23	Warnings	Exact identifier application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33	ZINC OXIDE	Eva's Esthetics	0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc7	2026-03-23	Warnings	Exact identifier application number: M020
MELAO Rice Probiotics Sunscreen	ZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATE	Guangdong Aimu Biological Technology Co., Ltd	4ccaa734-83c1-611b-e063-6294a90ab3bf	2026-03-21	Warnings	Exact identifier application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down Cake	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	69022828-8226-4977-a2ca-ad8e16793a59	2026-03-20	Warnings	Exact identifier application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	c7794831-52d1-4d80-936d-44af18ae0472	2026-03-20	Warnings	Exact identifier application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen	ZINC OXIDE	CA-Botana International	4d74a36c-ff68-afd9-e063-6394a90a08f8	2026-03-20	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	468d4ed2-e616-aaaf-e063-6294a90af37a	2026-03-20	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