Home NDC 80971-102 Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
Product NDC 80971-102
11-digit product format 809710102
Labeler code 80971
Product ID 80971-102_440aeb9e-256f-4e8a-e063-6394a90a9391
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Norwex Usa, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 28.8; 68 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 28.8 mg/mL ZINC OXIDE 68 mg/mL
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80971-102-01 Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30 50 mL in 1 TUBE CREAM 50 7 80971-102-01 Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80971-102 PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NORWEX USA, INC.] 6 Current NDC, 2 package rows 20250101_f527a8c5-b05e-5f3c-e053-2995a90aa1a3.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 361 · 7,213 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80971-102-01 80971010201 1 TUBE in 1 CARTON (80971-102-01) / 50 mL in 1 TUBE 1 tube 2023-01-01 No No Current