Home NDC 85634-212 Mineral Lip Sunscreen Tinted
Product NDC 85634-212
11-digit product format 856340212
Labeler code 85634
Product ID 85634-212_45b433c3-b48f-e64e-e063-6394a90a8f45
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-11
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 55; 40 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Sunscreen Tinted
Listing expiration 2026-12-31 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 85634-212-45 Mineral Lip Sunscreen Tinted 1 in 1 CARTON STICK 1 2 85634-212-45 Mineral Lip Sunscreen Tinted 4.5 g in 1 CYLINDER STICK 4.5 2
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 136 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join illuminating mineral mousse TITANIUM DIOXIDE, ZINC OXIDE NEXTEX CORPORATION 35bb4d67-373f-f60c-e063-6394a90a974d 2025-12-11 Exact identifier application number: M020 Soft Focus Mineral Defense Tinted TITANIUM DIOXIDE, ZINC OXIDE SPOTLESS SKIN STUDIO 387f1ea9-4764-3abe-e063-6394a90adde0 2025-12-11 Exact identifier application number: M020 flawless photo finish ZINC OXIDE NEXTEX CORPORATION 35bb0ac4-6abd-ca75-e063-6394a90a26cd 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352efbee-cab4-c515-e063-6294a90a46f2 2025-12-11 Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LEDUC, XUANTO MD 387e6e79-94db-dbb1-e063-6394a90aefd6 2025-12-11 Exact identifier application number: M020 Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352f5c53-3075-f437-e063-6394a90a4c4e 2025-12-11 Exact identifier application number: M020 Prevention TITANIUM DIOXIDE, ZINC OXIDE Noble Center for Healthy Aging LLC 387dbf46-4316-a15d-e063-6394a90adeb1 2025-12-11 Exact identifier application number: M020 Gentle Defense Sunscreen ZINC OXIDE Mint Skin Incroporated 352fe5e4-8b3f-248f-e063-6394a90ab42c 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incorporated 352f8de3-8ff0-4098-e063-6294a90ace4d 2025-12-11 Exact identifier application number: M020 Tinted Matte Defense Sunscreen Primer TITANIUM DIOXIDE, ZINC OXIDE Mint Skin Incroporated 35305bf1-8947-f275-e063-6294a90a3024 2025-12-11 Exact identifier application number: M020 Gentle Defense Sunscreen ZINC OXIDE Mint Skin Incorporated 3530898c-7bdf-6ffe-e063-6394a90aa037 2025-12-11 Exact identifier application number: M020 Equate SPF 50 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walmart Inc 45b4d41b-c9ac-2c26-e063-6294a90a614f 2025-12-11 Warnings Exact identifier application number: M020 Mint Condition ZINC OXIDE Mint Skin Incorporated 353031d7-cc2d-426c-e063-6394a90a99ea 2025-12-11 Exact identifier application number: M020 Body Protect ZINC OXIDE Noble Center for Healthy Aging LLC 387df843-b7d3-df2e-e063-6294a90a93f2 2025-12-11 Exact identifier application number: M020 Everyday Mineral Tinted Sunscreen ZINC OXIDE Atlanta Acne Specialists, LLC 351e6ca8-c6cb-dd99-e063-6294a90af0cf 2025-12-11 Exact identifier application number: M020 Mint Condition ZINC OXIDE Mint Skin Incorporated 3530efd2-b122-9aba-e063-6394a90a8953 2025-12-11 Exact identifier application number: M020 The Tinted Mineral Sunscreen ZINC OXIDE The Hue Solution L.L.C. 37f30a04-8ffa-09de-e063-6294a90aba05 2025-12-11 Exact identifier application number: M020 Abib Airy clear sunscreen gel Smoothing tube HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Fourcompany Co., Ltd. 33d1a5da-68c3-b16e-e063-6294a90a7006 2025-12-10 Warnings Exact identifier application number: M020 Non Tinted Mineral Moisturizing Sunscreen ZINC OXIDE ABOUT FACE AESTHETICS, INC. 3647a985-5365-a9e0-e063-6294a90ac0a4 2025-12-10 Exact identifier application number: M020 ProtectME Tinted Mineral SPF 40 20% ZINC OXIDE PUREFECTION LA, INC. 33dd1afa-25a8-891f-e063-6294a90a8c8a 2025-12-10 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 85634-212-45 85634021245 1 CYLINDER in 1 CARTON (85634-212-45) / 4.5 g in 1 CYLINDER 1 cylinder 2023-04-11 No No Current