Home NDC 42851-055 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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 27 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC ZINC OXIDE Colorescience d46533c7-c92d-d161-e053-2995a90a8e4b 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Glow ZINC OXIDE Colorescience cdb5397a-c463-4b41-e053-2a95a90a9e03 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Matte ZINC OXIDE Colorescience cd879b3e-16a2-2cca-e053-2a95a90a14f8 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Body Shield ZINC OXIDE Colorescience cdb413bb-58ab-1e0f-e053-2995a90aab0f 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Flex ZINC OXIDE Colorescience cdb55347-aedd-4de6-e053-2a95a90afec7 2026-05-21 Warnings Exact identifier application number: M020 Odacite Flex Perfecting Mineral Drops Tinted Sunscreen ZINC OXIDE Odacite 52560b2d-ebb5-5d96-e063-6294a90a15ee 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Bronze ZINC OXIDE Colorescience cdb577e4-5c80-7eac-e053-2a95a90a105b 2026-05-21 Warnings Exact identifier application number: M020 Mineral SPF 30 Moisturizer MINERAL SPF 30 MOISTURIZER Dont Run Out Inc (DBA: Public Goods) 52462e7e-0c2c-6b64-e063-6394a90a4230 2026-05-21 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52564e2f-983d-89ba-e063-6394a90ab424 2026-05-21 Warnings Exact identifier application number: M020 DRMTLGY Radiance Powder TITANIUM DIOXIDE, ZINC OXIDE DRMTLGY 15bda8d5-8c3c-6ba5-e063-6394a90a82d9 2026-05-21 Warnings Exact identifier application number: M020 Agent Natuer holi (sun) dewy tinted skin drops ZINC OXIDE Agent Natuer 043734b8-9aee-cdf1-e063-6294a90aec60 2026-05-21 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09bb5f97-f4db-a2d4-e063-6394a90a84fd 2026-05-21 Warnings Exact identifier application number: M020 Skin Metal Green Stealth ZINC OXIDE Skin Metal 47f562cc-48cc-97f9-e063-6294a90a7216 2026-05-21 Warnings Exact identifier application number: M020 Blume Sunburst Sunscreen ZINC OXIDE Blume 21ef2c6b-8ae7-8bcf-e063-6294a90ae9e1 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST13 KAMARI) ZINC OXIDE Ilia, Inc. b595ca2c-177e-b357-e053-2995a90a54f6 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6 ORA) ZINC OXIDE Ilia, Inc. b59537d4-e1d8-53e4-e053-2995a90a2ce3 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16 PAVONES) ZINC OXIDE Ilia, Inc. b595f1e9-36f7-615d-e053-2a95a90abb1c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO) ZINC OXIDE Ilia, Inc. b97dc2ac-dd6d-403d-e053-2995a90a0d9c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA) ZINC OXIDE Ilia, Inc. b595db16-7969-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11 MATIRA) ZINC OXIDE Ilia, Inc. b595b5f0-dd3d-79ef-e053-2a95a90ad9fb 2026-05-21 Warnings Exact identifier application number: M020
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