Home NDC 85563-212 Mineral Lip Protection
Product NDC 85563-212
11-digit product format 855630212
Labeler code 85563
Product ID 85563-212_46041f25-f600-ee00-e063-6394a90aaa56
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler CLEAR SKIN SOLUTIONS, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-11
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 55; 40 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Mineral Lip Protection
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 55 mg/g TITANIUM DIOXIDE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85563-212-45 Mineral Lip Protection 4.5 g in 1 CYLINDER STICK 4.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85563-212 MINERAL LIP PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) STICK [CLEAR SKIN SOLUTIONS, LLC] 1 Current NDC, 1 package rows 20250523_35bd148c-43c7-aa93-e063-6394a90abc8b.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 286 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join H.E.B Solutions Sunscreen KIDS SPF 50 LOTION SPRAY H.E.B 9b43c5d5-c279-4ae3-843e-1451f7324216 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 CONTINUOUS SPRAY H.E.B 2e183ba8-1b83-4211-bc08-dbdcee942ce9 2024-10-15 Warnings Exact identifier application number: M020 EQUALINE KIDS SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE United Natural Foods, Inc. dba UNFI e46cb6e3-ea8d-3c2d-e053-2a95a90a0bf6 2024-10-15 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SUNSCREEN Bentley Laboratories LLC 782a8641-7e6a-413b-a2ed-0efeb36c48a7 2024-10-15 Warnings Exact identifier application number: M020 H.E.B MANGO SPF 50 SUNSCREEN H.E.B 35898f07-2973-461a-91b8-095aa4cf38ee 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 30 CONTINUOUS SPRAY H.E.B 8b6d0c0d-485b-4428-91e5-5befcac18d5d 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 CONTINUOUS SPRAY H.E.B 5fd3d730-d916-48f4-bb94-62d40d181280 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 70 CONTINUOUS SPRAY H.E.B f9b5b360-6b69-4006-934f-5bc8a9fdfcd0 2024-10-15 Warnings Exact identifier application number: M020 HEB GENERAL PROTECTION SPF 100 LOTION H-E-B 39d94e3a-98c8-44b0-bd2d-f318ac7bbf75 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen WET PROTECTION KIDS SPF 70 CONTINUOUS SPRAY H.E.B f823b236-5884-41d9-bff0-65b91664aaad 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen COOLING SPORT SPF 50 CONTINUOUS SPRAY H.E.B 67fdf3a0-08fe-4348-a4f9-a83f3cf46b72 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 70 CONTINUOUS SPRAY H.E.B c16935ce-afdb-4571-b5a3-6dc5d01f721c 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen BABY SPF 50 LOTION SPRAY H.E.B 1082111f-bf04-4a98-b6a0-5da933652f1d 2024-10-15 Warnings Exact identifier application number: M020 H.E.B ULTRA SPF 50 SUNSCREEN H.E.B d6184ba2-0e47-459a-8777-1f27be2140a6 2024-10-15 Warnings Exact identifier application number: M020 H.E.B ULTRA SPF 30 SUNSCREEN H.E.B 90287874-cdfa-489c-936d-e487f6b3db96 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 2c9258ac-8cbe-4acf-9c02-bb993d69a3e5 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 39bf1379-3dee-4aa0-967a-36faccca4216 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 100 CONTINUOUS SPRAY H.E.B 301ae7e5-5a60-45d0-8cd5-553ba07db4c5 2024-10-15 Warnings Exact identifier application number: M020 Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C HOMOSALATE, ZINC OXIDE Rare Beauty, LLC 2470d78c-724f-4181-e063-6294a90afeaa 2024-10-14 Warnings Exact identifier application number: M020 Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N HOMOSALATE, ZINC OXIDE Rare Beauty, LLC 2471e0fa-ddc8-1c62-e063-6294a90a4408 2024-10-14 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85563-212-45 85563021245 4.5 g in 1 CYLINDER (85563-212-45) 4.5 g 2019-07-11 No No Current