Home NDC 0316-0300 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen
Product NDC 0316-0300
11-digit product format 003160300
Labeler code 0316
Product ID 0316-0300_45879704-3fc3-1616-e063-6394a90afe59
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-25
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 66.6; 99.9 mg/mL; mg/mL
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 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 66.6 mg/mL TITANIUM DIOXIDE 99.9 mg/mL
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 0316-0300-50 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen 1 in 1 CARTON LOTION 1 4 0316-0300-50 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen 50 mL in 1 TUBE LOTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0300 BIOJUVE MICROBIOME-SAFE SHEER FINISH SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES] 3 Current NDC, Legacy NDC, 2 package rows 20241103_ece7565b-f3e5-3386-e053-2a95a90a5802.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0316-0300-50 00316030050 1 TUBE in 1 CARTON (0316-0300-50) / 50 mL in 1 TUBE 1 tube 2022-10-25 0000-00-00 No No Current