Home NDC 85767-610 Reflecting Mineral Sunscreen
Product NDC 85767-610
11-digit product format 857670610
Labeler code 85767
Product ID 85767-610_3750f04b-7fa0-8793-e063-6294a90a9143
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler Helande, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-01
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength .135; .023 g/100mL; g/100mL
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 Reflecting Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .135 g/100mL TITANIUM DIOXIDE .023 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 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 85767-610-01 Reflecting Mineral Sunscreen 30 mL in 1 BOTTLE, PLASTIC LOTION 30 1 85767-610-01 Reflecting Mineral Sunscreen 1 in 1 BOX LOTION 1 1
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 26 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85767-610-01 85767061001 1 BOTTLE, PLASTIC in 1 BOX (85767-610-01) / 30 mL in 1 BOTTLE, PLASTIC 2025-07-01 No No Current