Home NDC 83286-014-01 Broad Spectrum SPF45
Product NDC 83286-014
Requested package NDC 83286-014-01
11-digit product format 832860014
Labeler code 83286
Product ID 83286-014_4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Octinoxate
Dosage form GEL
Route TOPICAL
Labeler Drmtlgy, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-01
Substance ZINC OXIDE; OCTINOXATE
Active strength 12; 7.5 g/100mL; g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Broad Spectrum SPF45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/100mL OCTINOXATE 7.5 g/100mL
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 4Y5P7MUD51 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 83286-014-01 Broad Spectrum SPF45 50 mL in 1 BOTTLE GEL 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-014 BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] 1 Current NDC, 1 package rows 20250508_0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8.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 117 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stellar Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6488c-d216-8742-e063-6394a90a16e2 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb8ee19-81b2-daed-e063-6394a90a0fb3 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43 2025-12-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 35442ac0-c361-e08f-e063-6294a90a5cb2 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543e85d-9bc7-b8ed-e063-6294a90ae7d3 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bc8593d-fc6c-04aa-e063-6394a90a6d56 2025-12-15 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE MANTRA WELLNESS SPA 338855fd-3008-44d9-e063-6294a90a5e07 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE MANTRA WELLNESS SPA 33898415-4ee6-a384-e063-6394a90ae8e1 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Mantra Wellness Spa 3389b0a3-40f9-b411-e063-6394a90a9959 2025-12-15 Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE Mantra Wellness Spa 338a11fb-24c6-8a0b-e063-6294a90a761e 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Mantra Wellness Spa 338aa5a2-29e3-fe0e-e063-6294a90a18fd 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39959db9-5ee1-a27c-e063-6394a90a1e10 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995f556-20fe-3e64-e063-6294a90a5efe 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995385b-b10b-ca5c-e063-6294a90af43f 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3994aa84-30b4-3dc4-e063-6394a90a23e7 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39947913-f1cc-25d2-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35425e24-3e2c-51db-e063-6394a90a5580 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396fe2ca-eb29-5952-e063-6294a90ab279 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f91b3-3326-3239-e063-6294a90a5df9 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35422370-eb55-049c-e063-6294a90ad0a4 2025-12-15 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 83286-014-01 83286001401 50 mL in 1 BOTTLE (83286-014-01) 50 ml 2025-05-01 No No Current