Home NDC 85387-258 Essential Mineral Sun Protection
Product NDC 85387-258
11-digit product format 853870258
Labeler code 85387
Product ID 85387-258_45b370ec-f575-b104-e063-6294a90a105b
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Fern Burg
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-13
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 100; 30 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 Essential Mineral Sun Protection
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 100 mg/g ZINC OXIDE 30 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85387-258-50 Essential Mineral Sun Protection 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85387-258 ESSENTIAL MINERAL SUN PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FERN BURG] 1 Current NDC, 1 package rows 20250510_34a360b2-6798-c7e8-e063-6294a90a5cbb.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 177 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AESOP Avail Body Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd 2cb40521-94ed-4e76-a4e2-de1c80155bd2 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd bff60c2f-0cc6-493b-81a0-ed35e9746146 2025-10-17 Warnings Exact identifier application number: M020 Mineral Lip Balm Pineapple ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 667714f6-38bc-4c94-aacc-24b46e8e59fd 2025-10-17 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY ZINC OXIDE Eco-Chic LLC dd2fe82e-31e1-1349-e053-2995a90aa409 2025-10-16 Warnings Exact identifier application number: M020 Hello Bello Kids SPF 50 Face and Body Sunscreen Stick ZINC OXIDE Hello Bello 4127e49a-eb27-e8e2-e063-6294a90a469e 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN UNRIVALED SERUM ZINC OXIDE Eco Chic, LLC f4bdacb9-bedd-c9cc-e053-2995a90a5786 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS ACE THE DAY Face ZINC OXIDE Eco-Chic LLC de438665-72d9-9b1b-e053-2a95a90ab9ef 2025-10-16 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6bb07f16-c3a3-49e7-ae13-718bb0055873 2025-10-16 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 40 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 124e6702-97a4-95bf-e063-6394a90afc0d 2025-10-16 Warnings Exact identifier application number: M020 Perfecting Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c1186-6f68-3828-e063-6294a90a66cf 2025-10-16 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c2db8-3122-60d3-e063-6394a90ae1c8 2025-10-16 Warnings Exact identifier application number: M020 DD Cream DD CREAM DERMAdoctor, Inc. 08c9a0cf-ee78-483b-e054-00144ff88e88 2025-10-16 Warnings Exact identifier application number: M020 Ciele Bronze and Protect ZINC OXIDE Ciele LLC 22003cbf-5a6d-001b-e063-6394a90aefdd 2025-10-15 Warnings Exact identifier application number: M020 Ciele Blush and Protect ZINC OXIDE Ciele 0162c891-ba2d-a78f-e063-6394a90a156c 2025-10-15 Warnings Exact identifier application number: M020 Ciele Filter and Protect TITANIUM DIOXIDE, ZINC OXIDE Ciele 0309b0ef-baca-b41d-e063-6294a90a49d7 2025-10-15 Warnings Exact identifier application number: M020 Ciele Sculpt and Protect ZINC OXIDE Ciele LLC 21ff7f78-b543-0bea-e063-6294a90aed70 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREEN ZINC OXIDE Lather, Inc. 3158a2d7-0db5-f5bf-e063-6294a90a3126 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 ZINC OXIDE Lather, Inc. 81cf57b0-6072-432f-b421-7d1a708da1c4 2025-10-15 Warnings Exact identifier application number: M020 Ciele Glow and Protect ZINC OXIDE Ciele Cosmetics 27310d47-de1b-2149-e063-6394a90abe83 2025-10-15 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Sport Stick ZINC OXIDE Colorescience d3c0d2b0-f411-565d-e053-2a95a90a081b 2025-10-15 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 85387-258-50 85387025850 53 g in 1 BOTTLE, PUMP (85387-258-50) 53 g 2023-06-13 No No Current