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 73 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	310a07bb-d32a-401f-955e-4c2860148a30	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	39ae4a97-7f96-4c95-a6de-0c779764fb02	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc3e-055c-e51d-e063-6294a90a00f5	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	9c7a31df-5bdd-403b-b807-1d1a801e1bb6	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc51-ae53-acb8-e063-6394a90a14eb	2026-01-20	Warnings	Exact identifier application number: M020
Wrinkle Repair Moisturizer SPF 30 EQB	AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%	Walmart	a067e968-e598-40ef-95f2-c338b5e413dd	2026-01-20	Warnings	Exact identifier application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Welmedix LLC	48da4589-0f5a-c25b-e063-6394a90ac18b	2026-01-20	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Kids	ZINC OXIDE 14.69%	S&C Hampton Sun LLC	0bdb7d15-dc52-4e23-9417-fe73f17f6110	2026-01-20	Warnings	Exact identifier application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK	OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE	DEWYTREE CO. ,LTD	48406e68-eefd-d2c2-e063-6394a90a4ad9	2026-01-20	Warnings	Exact identifier application number: M020
KONEUK SUNSCREEN SPF50	KONEUK SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	48dd7f6e-2a4d-2c92-e063-6294a90a4255	2026-01-20	Warnings	Exact identifier application number: M020
CHUDA	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	Premier Ocher LLC	1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f	2026-01-20	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	12edec55-2414-4bbd-bc96-4599a96b96ac	2026-01-19	Warnings	Exact identifier application number: M020
PROJECT REEF SPF-30 Mineral Sunscreen	ZINC OXIDE	Project Reef LLC	a6077e6f-d987-4159-946f-3e2397247659	2026-01-19	Warnings	Exact identifier application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	86ee2fdf-8a88-44e6-b12a-36a92360477a	2026-01-19	Warnings	Exact identifier application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30	ZINC OXIDE	SABAL SUN LLC	f917b446-4e10-4231-826e-fdac32e11186	2026-01-19	Warnings	Exact identifier application number: M020
Plius Daily SPF Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	PLIUS, Inc	31866de9-afa0-4c11-be65-b61373551493	2026-01-19	Warnings	Exact identifier application number: M020
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	6edc0941-bb21-4797-a875-81f727694774	2026-01-19	Warnings	Exact identifier application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)	ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%	Grace and Fire USA Inc.	48c1b93c-9c6f-95aa-e063-6294a90a0cfa	2026-01-19	Warnings	Exact identifier application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	446ac344-1078-4cd1-e063-6294a90a4bd4	2026-01-19	Warnings	Exact identifier application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	31af7b5e-2bd6-63ee-e063-6294a90a0806	2026-01-19	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