Home NDC 85362-212 Tinted Lip Balm
Product NDC 85362-212
11-digit product format 853620212
Labeler code 85362
Product ID 85362-212_4603db8e-2444-c231-e063-6294a90a31bf
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Goldberg, Howard S MD Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-07
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 40; 55 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 Tinted Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 40 mg/g ZINC OXIDE 55 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 85362-212-45 Tinted Lip Balm 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 85362-212 TINTED LIP BALM (TITANIUM DIOXIDE, ZINC OXIDE) STICK [GOLDBERG, HOWARD S MD INC] 1 Current NDC, 1 package rows 20250523_3598205d-2e87-9292-e063-6294a90a1f2a.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 173 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avinichi Noni Sol Shield Cream SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 9e534e32-efea-4dcf-adc1-18de3847ac04 2025-10-30 Warnings Exact identifier application number: M020 MOOYAM Dark Skin Sunscreen SUNSCREEN Guangdong Bisutang Biotechnology Co., LTD 4246e9f1-1c51-d888-e063-6394a90abda0 2025-10-29 Warnings Exact identifier application number: M020 Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE THG Beauty USA LLC 1cd10158-c346-60c9-e063-6294a90a54bd 2025-10-29 Warnings Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Clove Hill LLC 311b270f-b9e2-2374-e063-6294a90af581 2025-10-29 Warnings Exact identifier application number: M020 Hello Bello Kids Mineral Sunscreen ZINC OXIDE TITANIUM OXIDE Hello Bello 3e7a3e8e-eacf-0a30-e063-6294a90ab7ec 2025-10-29 Warnings Exact identifier application number: M020 Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25 TITANIUM DIOXIDE THG Beauty USA LLC 23f4cf41-0eed-2df3-e063-6294a90ad402 2025-10-28 Warnings Exact identifier application number: M020 goPure Sunscreen ZINC OXIDE Natural Lifestyle Brands, LLC dba GoPure beauty a74ec20b-8436-4030-820c-01fd88134f40 2025-10-27 Warnings Exact identifier application number: M020 KidsBliss Baby and Kids Mineral Sunscreen SPF50 ZINC OXIDE VeganicSKN 2dfa236f-128b-17bb-e063-6294a90aa29c 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd7477-445f-d1d5-e063-6394a90a4607 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun reef safe Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd936b-0ea6-03a2-e063-6394a90a4fba 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 years ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de1cd7-fdfd-7f7a-e063-6394a90a9b5c 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 7 years to adult ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de09dc-544f-9780-e063-6394a90acd27 2025-10-24 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 23670a30-6619-0651-e063-6394a90af978 2025-10-24 Warnings Exact identifier application number: M020 PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 397b4338-fec8-5228-e063-6394a90ad97d 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 38c80373-1d5a-c7f4-e063-6294a90aa9c2 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 ZINC OXIDE, TITANIUM DIOXIDE THG Beauty USA LLC 254b4692-a459-6119-e063-6394a90a0a60 2025-10-23 Warnings Exact identifier application number: M020 AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENE CHOP SAVER FRESH CITRUS SPF 15 LIP BALM Good for the Goose Products, LLC 2786cec8-0b8e-9c83-e063-6394a90ab338 2025-10-23 Warnings Exact identifier application number: M020 Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Naturopathica Holistic Health 41d75815-e281-bf88-e063-6294a90afeff 2025-10-23 Warnings Exact identifier application number: M020 Thrive Daily Sunscreen For Sensitive Skin SPF 30 ZINC OXIDE Thrive Natural Care, Inc 128e1a3a-df40-f51c-e063-6394a90a1902 2025-10-23 Warnings Exact identifier application number: M020 Thrive Bodyshield 50 SPF 50 ZINC OXIDE Thrive Natural Care, Inc 12d9e1d0-c59c-f770-e063-6294a90a8191 2025-10-23 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 85362-212-45 85362021245 4.5 g in 1 CYLINDER (85362-212-45) 4.5 g 2025-01-07 No No Current