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 26 of 357 · 7,139 matching rows.
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