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 86 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROE WELLNESS SPF 50 MINERAL	SPF 50 MINERAL POWDER	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dc8155-4abb-4bb7-e063-6294a90af1ad	2026-01-08	Warnings	Exact identifier application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERAL	SUNSCREEN SPF50	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dd07aa-71b4-5d54-e063-6394a90a4127	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45	SUNSCREEN SETTING SPRAY	Aopline Biotechnology (Guangzhou) Co., Ltd.	47ddf752-cae2-313f-e063-6294a90a7e3a	2026-01-08	Warnings	Exact identifier application number: M020
St Moriz suncare face sunscreen spf50	OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df072e-151f-eb30-e063-6294a90a4eeb	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN GLOWING	AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df0de5-012a-c896-e063-6394a90a9cef	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35f6-63d2-3d26-e053-2991aa0a5b44	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35a1-a139-1974-e053-2a91aa0a20b6	2026-01-08	Warnings	Exact identifier application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen	SPF 30	EVI LABS	258b7b7c-a3f2-172c-e063-6394a90aec6a	2026-01-08	Warnings	Exact identifier application number: M020
DMK Ultrascreen Mineral Sunscreen	ZINC OXIDE	Danne Montague King	3f022275-c1e5-2704-e063-6294a90a4a81	2026-01-08	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68	2026-01-08	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products, LLC	47e5198e-7bf6-72a8-e063-6294a90a7ec5	2026-01-08	Warnings	Exact identifier application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM	INDE WILD SUN DEFENSE GLOW DROPS	INDE WILD PRIVATE LIMITED	47e57407-2925-09ca-e063-6294a90a49ec	2026-01-08	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sunscreen	SUNSCREEN	Proso Corp	47ed3b62-45ef-b67a-e063-6294a90a317b	2026-01-08	Warnings	Exact identifier application number: M020
Organic Matters SPF 50 Sunscreen	ZINC OXIDE	Veganic SKN Limited	12f37c8d-07f0-3e75-e063-6294a90a2cdf	2026-01-08	Warnings	Exact identifier application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Veganic SKN Limited	161a7209-10d8-928c-e063-6394a90a4139	2026-01-08	Warnings	Exact identifier application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and face	ZINC OXIDE	Veganic SKN Limited	1a97169e-67be-3d25-e063-6294a90a3b88	2026-01-08	Warnings	Exact identifier application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	1208d0f8-bb12-4574-b70e-3a76b11a64c7	2026-01-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KDC/One Development Corporation, Inc.	259f3fe3-2967-6c05-e063-6394a90a9e45	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	4084dd98-357f-4011-b0d4-db6536d2931f	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	9b4acc5e-fdaf-4fcb-83a9-69e430dd43de	2026-01-07	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