Home NDC 68577-158 NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30
Product NDC 68577-158
11-digit product format 685770158
Labeler code 68577
Product ID 68577-158_2a26aea8-18cb-1305-e063-6294a90a16f0
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler COSMAX USA, CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 2.88; 6.8 mg/100mg; mg/100mg
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 NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 2.88 mg/100mg ZINC OXIDE 6.8 mg/100mg
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68577-158-01 NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 1 in 1 CARTON LOTION 1 2 68577-158-01 NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 50 mg in 1 TUBE LOTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68577-158 NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COSMAX USA, CORPORATION] 2 Current NDC, 2 package rows 20241228_0d489154-6168-977e-e063-6394a90aa609.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 Sample Exclude flag Status 68577-158-01 68577015801 1 TUBE in 1 CARTON (68577-158-01) / 50 mg in 1 TUBE 1 tube 2023-09-01 No No Current