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 66 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOW	HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%	S&C Hampton Sun LLC	26190992-9463-47ae-86a5-0dbc05be8773	2026-02-02	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Rite Aid Corporation	fe9146ec-b85d-43da-a391-377960f2c772	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	299a6690-9746-4410-a625-7636f0b4a754	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
Dr. C. Tuna Sun Stick SPF 50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Farmasi US LLC	49dc6040-b400-7f5b-e063-6394a90ac7d7	2026-02-02	Warnings	Exact identifier application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50	ZINC OXIDE	e.l.f. Cosmetics, Inc	535f798f-d21d-92b2-e063-6294a90a72c7	2026-02-02	Warnings	Exact identifier application number: M020
Sol de Janiero Rio Radiance SPF 50 Body	ZINC OXIDE	Cosmetic Solutions LLC	2d54727d-5dcc-4792-85e8-1a2f21fe9e3d	2026-02-02	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 50	ZINC OXIDE	Delta Ecommerce LLC	47d9dc66-328f-4cab-e063-6394a90a279d	2026-02-01	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f cosmetics,Inc.	4b801bb3-8930-7e04-e063-6294a90adaa1	2026-02-01	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEAR	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	cedd7a3e-3334-437f-a283-482bcd0064ee	2026-01-30	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	bf16e8b5-b717-4255-a7da-9abe3d1ad8b4	2026-01-30	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	372a8fba-b190-40fe-a1fc-fecf7f7afc35	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M020
ALOE UP MEDICATED LIP BALM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	859b6d3f-b1ca-4966-8f0c-f9afa0d5864c	2026-01-30	Warnings	Exact identifier application number: M020
ALOE UP SPORT NATURAL BALM SPF-15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	3de029ed-97f7-4cb3-a32e-d412bf3b5874	2026-01-30	Warnings	Exact identifier application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier application number: M020
Touch in SOL No Poreblem Airbrushed Primer	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	BONNE Co., Ltd	4685ff24-0bb0-3502-e063-6394a90abfee	2026-01-29	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Aldi, Inc	c7650d20-7cb9-4861-8a30-cf4a9cd424e9	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Aldi, Inc	32c0613e-0f5a-47f5-b2f3-f32ae07cbc76	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M020
Vacation Original Coconut SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	a9a0b558-b8e6-44ea-9b57-6938837a04fb	2026-01-29	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