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 67 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO SPORTS BB DARK	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	f4fc4b6a-9507-496e-9ecb-8400055ecf2d	2026-01-28	Warnings	Exact identifier application number: M020
Hampton Sun SPF 30 Mineral	ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	b8ee428e-07d3-4c6c-853c-cfbe3e4002d9	2026-01-28	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE S	OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	0a6f8eef-48e9-44f5-9811-629bc0dc07d0	2026-01-28	Warnings	Exact identifier application number: M020
Hampton Sun SPF 45 Tinted Face	HOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%	S&C Hampton Sun LLC	0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b	2026-01-28	Warnings	Exact identifier application number: M020
Walgreens 70 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	49775d1a-e573-a596-e063-6294a90a7cf6	2026-01-28	Warnings	Exact identifier application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONE	The Avon Company	49784430-2ffe-0cbb-e063-6394a90adb23	2026-01-28	Warnings	Exact identifier application number: M020
ALOE UP SPORT SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	3f2f90f1-28dd-48e8-9083-ea04815acc6b	2026-01-28	Warnings	Exact identifier application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	baf32d84-4db5-4ed0-9814-5470b7d1f4a4	2026-01-28	Warnings	Exact identifier application number: M020
ALOE UP PRO 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd	2026-01-28	Warnings	Exact identifier application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	dc33d9e8-3463-485d-a1ee-6319ed91454c	2026-01-28	Warnings	Exact identifier application number: M020
ALOE ICE SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	e4b861d2-3680-4ed7-8650-d1d839da5ab2	2026-01-28	Warnings	Exact identifier application number: M020
ALOE UP SPORT SPF-15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	1bf1635a-825e-417f-97b4-4bce6d251d19	2026-01-28	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE 20%	The Daily Suncare LLC, DBA Daily Shade	1a392f6b-1bb1-c49d-e063-6294a90a791d	2026-01-28	Warnings	Exact identifier application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	YB CHEMIA LLC	0053ae49-b9a1-c3f4-e063-6394a90abcb8	2026-01-28	Warnings	Exact identifier application number: M020
Orange Gel	AVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATE	Vacation Inc.	132896ef-d6c6-4ec7-e063-6294a90a103b	2026-01-28	Warnings	Exact identifier application number: M020
REDEFINE Triple Defense	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	d1dd62c6-33ac-4941-ab99-9eb8cc3c208a	2026-01-27	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e11009-ffcb-dd59-e063-6294a90add22	2026-01-27	Warnings	Exact identifier application number: M020
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M020
ONSART Mineral Sunscreen SPF 50	ZINC OXIDE 24%	Guangzhou Huixue Biotechnology Co., Ltd.	495e3266-a59f-42f7-e063-6394a90adfa3	2026-01-27	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	54868d6f-ae4c-476d-8c77-c4a72b13d2ea	2026-01-27	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