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 42 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EltaMD UV Restore Tinted TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc. 6a48ad0d-20e4-44b1-90d6-30bfbc68a152 2026-04-17 Warnings Exact identifier application number: M020 Pacto Refreshing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Mynd LLC 56ad7c97-3dae-4bac-a677-f5052dfdfea4 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f95cd0a-f996-648b-e063-6294a90adc28 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f968058-e851-86d0-e063-6294a90aa786 2026-04-16 Warnings Exact identifier application number: M020 Red Cherry SPF 15 Broad Spectrum Lip Balm RED CHERRY SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 4f96d057-39b8-e4d5-e063-6394a90acb5c 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f970778-97d6-40a9-e063-6394a90a6c89 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-Light ZINC OXIDE ZO Skin Health, Inc. 4f9988a0-ae4a-9940-e063-6294a90ad91d 2026-04-16 Warnings Exact identifier application number: M020 MELAO Hydrating Mineral Sunscreen TITANIUM DIOXIDE,ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4f778eb0-55f7-38d0-e063-6394a90a69a0 2026-04-15 Warnings Exact identifier application number: M020 Tanning Club Everyday Sunscreen SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE TANNING CLUB, LLC 75820400-a5e0-4cf5-8b4f-a52500ce62c3 2026-04-15 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f81e482-8111-451c-e063-6294a90ad148 2026-04-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f8353b3-4ac1-9703-e063-6294a90abdad 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f83dd76-a8d8-916e-e063-6294a90ab6ed 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick - Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f84619f-3415-7443-e063-6394a90a162a 2026-04-15 Warnings Exact identifier application number: M020 Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory TITANIUM DIOXIDE AND ZINC OXIDE PML NYC, LLC 1be639a8-179a-7015-e063-6394a90ab64b 2026-04-15 Warnings Exact identifier application number: M020 PHELITYL DAY SPF 15 PHELITYL DAY SPF 15 PML NYC, LLC ea9d33d9-6f9f-0a66-e053-2a95a90abd42 2026-04-15 Warnings Exact identifier application number: M020 FIRMARINE MOISTURIZER SPF 30 FIRMARINE MOISTURIZER SPF 30 PML NYC, LLC ea9db179-1b69-01e0-e053-2a95a90a1628 2026-04-15 Warnings Exact identifier application number: M020 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 PML NYC, LLC eaa562b1-3fc6-1a85-e053-2995a90ad1ec 2026-04-15 Warnings Exact identifier application number: M020 DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 PML NYC, LLC ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 2026-04-15 Warnings Exact identifier application number: M020 RICH GIRL HAND SPF 25 RICH GIRL HAND PML NYC, LLC ea8f4421-109f-41a5-e053-2a95a90a3832 2026-04-15 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e24a63e-d76f-6581-e063-6394a90a6181 2026-04-15 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