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 285 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB SPF 50 Pomegranate Continuous AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b48729-43d3-72b4-e053-2995a90a9d85 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 For Men Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b682aa-a194-09ff-e053-2a95a90ade73 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Birthday Cake Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b755af-2bd3-33cf-e053-2a95a90a9961 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Watermelon Serbert Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f5b77cc0-1ed5-c4ae-e053-2a95a90abc1a 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6e0db20-594b-30a8-e053-6394a90a7164 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6dfe973-bd88-e0e4-e053-6394a90ac927 2024-10-15 Warnings Exact identifier application number: M020 HEB Face Primer 30 Sunscreen Face Primer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H-E-B f6e29c93-9fd9-36c6-e053-6394a90a1747 2024-10-15 Warnings Exact identifier application number: M020 H.E.B. Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE H.E.B. c5279caf-3af9-d163-e053-2995a90a943b 2024-10-15 Warnings Exact identifier application number: M020 HEB Face 50 Clear Zinc Sunscreen OCTOCRYLENE, ZINC OXIDE H.E.B. f6e3c883-0087-dcd6-e053-6394a90a1272 2024-10-15 Warnings Exact identifier application number: M020 HEB Mineral Sunscreen SPF 50 ZINC OXIDE H.E.B. de99343b-c74c-3f43-e053-2995a90ac9dd 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 55 Babies and Kids Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. f5660a97-57c8-61c7-e053-2995a90a0164 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 362f726b-d52b-4dae-ade6-a47de47697ef 2024-10-15 Warnings Exact identifier application number: M020 HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For Face ZINC OXIDE H.E.B. dfb43fc5-4968-f999-e053-2a95a90a0819 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BABY SPF 50 SUNSCREEN H.E.B 61273611-ab7a-4216-aebe-2c8d89660281 2024-10-15 Warnings Exact identifier application number: M020 H.E.B BANANA SPF 50 SUNSCREEN H.E.B b9a9837a-094b-4a57-a50c-5c1437deda7b 2024-10-15 Warnings Exact identifier application number: M020 HEB Solutions Sunscreen SPORT SPF 100 LOTION H.E.B 9e3ea66c-d6a0-49ca-a3c0-8175e0617453 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 50 LOTION H.E.B 12c76c72-4411-48d5-b79b-c58703bf1fdd 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 50 CONTINUOUS SPRAY H.E.B 86ad5d30-f700-42a2-b810-dd2e3ed0f2d8 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 1f8d4f91-9eb9-41de-9066-a7a08c7ff84f 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 100 CONTINUOUS SPRAY H.E.B be80244d-da6d-4d37-b228-4d3fac335caf 2024-10-15 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