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 104 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6da72e20-f2d7-492e-9b65-b5ac73bc0029 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior de615c3e-669f-493c-9c75-73dfbe726c59 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 152790ba-aeda-4c2a-b725-7e040e832883 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c87e5201-f7fd-4fd9-adeb-d6af9be00db6 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84cdaad2-5b7d-4841-bef6-ffad4fe6907a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b4caa2bc-8118-4137-8834-25800f8e5e01 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c0fa32fe-faa7-4a47-906c-14db01e55d47 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ff1a8b32-c01f-4910-9a7a-c74eb49c05a0 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d3bd710b-7d1a-4f96-9fbc-a67c550d863b 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 3b6ea0ec-4636-43cf-a324-a82666108e95 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ac7fb96-a2f2-4086-82ad-c45d7a709091 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84a5f7e1-1c04-43cd-8d3b-60c7e2418faf 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 28a61b11-5901-47ec-916c-e2ae4f79a11d 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ddf8221-9bfc-4c52-9a51-a0d725b7a23e 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5937248a-b96e-490a-9f93-10e65969ac10 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 62136c4c-6f05-4de0-a71e-55aa53160685 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a8037741-ec57-43e7-adb4-2a93941ee108 2025-12-19 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