Home NDC 85865-002 SPF 50 Mineral Sunscreen Face and Body
Product NDC 85865-002
11-digit product format 858650002
Labeler code 85865
Product ID 85865-002_52cc5adc-9233-e0ff-e063-6394a90a227e
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Toddle Born Wild, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-10
Substance ZINC OXIDE
Active strength 20 g/100mL
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 SPF 50 Mineral Sunscreen Face and Body
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 85865-002-01 SPF 50 Mineral Sunscreen Face and Body 50 mL in 1 TUBE LOTION 50 3 85865-002-02 SPF 50 Mineral Sunscreen Face and Body 100 mL in 1 TUBE LOTION 100 3 85865-002-03 SPF 50 Mineral Sunscreen Face and Body 177 mL in 1 PACKAGE LOTION 177 3
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 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85865-002-01 85865000201 50 mL in 1 TUBE (85865-002-01) 50 ml 2025-12-10 No No Current 85865-002-02 85865000202 100 mL in 1 TUBE (85865-002-02) 100 ml 2026-02-10 No No Current 85865-002-03 85865000203 177 mL in 1 PACKAGE (85865-002-03) 177 ml 2025-12-10 No No Current