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 35 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THANKYOU FARMER Sun Project Soothing Sun	OCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	THANK YOU FARMER CO., LTD	300ab1bc-9c11-c2f0-e063-6394a90aa853	2026-05-06	Warnings	Exact identifier application number: M020
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	9eb7f287-cb61-4f9d-968e-16b195dbbc9a	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier application number: M020
SPF 50 Dry Tropix with fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	2c95f5c0-7ff6-4eac-b2d6-49e7da7e7bec	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF30 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	9592835a-7c07-487e-a955-04fdea070809	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	65f52fc8-8ddb-4282-9bc0-92a7d0e0c0f2	2026-05-05	Warnings	Exact identifier application number: M020
Knesko Skin The Sunscreen	ZINC OXIDE	Knesko, LLC	5114dc75-a865-326e-e063-6294a90a8911	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	683cb489-e4e1-44ab-9543-614d42b08edd	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier application number: M020
Surface Sun SPF 50 Mineral Sunscreen	ZINC OXIDE 24%	Surface Products Corp	6f95de43-cb71-4ddd-b438-a35ee2e14fae	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Port Jervis Laboratories, Inc	5118a0a4-728b-6884-e063-6394a90a02b3	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baed7205-2e0d-c6aa-e053-2995a90a8e29	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baee366f-c1a0-5e21-e053-2a95a90a6687	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Sun and Soothe Moisturizing Lip Balm SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	fc4d2387-ce6a-4105-bab4-7d371b61f770	2026-05-05	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Soothing Sun	HOMOSALATE, OCTISALATE. AVOBENZONE	THANK YOU FARMER CO., LTD	3009df84-4ca7-e170-e063-6294a90a1578	2026-05-05	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Moisture Sun	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	THANK YOU FARMER CO., LTD	300d8526-0daf-2255-e063-6394a90a21b1	2026-05-05	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - FAIR	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa	2026-05-04	Warnings	Exact identifier application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - DEEP	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	930bd1de-5a0e-4607-8d3c-b1ca918f890b	2026-05-04	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Rice Tinted Mineral Sunscreen	ZINC OXIDE	THANK YOU FARMER CO., LTD	30086b1e-d876-2528-e063-6294a90a4e9f	2026-05-04	Warnings	Exact identifier application number: M020
Blue Berry SPF 15 Broad Spectrum Lip Balm	BLUE BERRY SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	50ff6ecb-c8b3-02fc-e063-6394a90a68de	2026-05-04	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