Home NDC 67676-009-01 Natural Mineral Sunscreen
Product NDC 67676-009
Requested package NDC 67676-009-01
11-digit product format 676760009
Labeler code 67676
Product ID 67676-009_16ef922d-78d2-1e70-e063-6394a90a3bbf
Type HUMAN OTC DRUG
Nonproprietary name titanium dioxide, zinc oxide
Dosage form LOTION
Route TOPICAL
Labeler Sarati International, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-16
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 4.95; 9.5 g/100g; g/100g
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 Natural Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 4.95 g/100g ZINC OXIDE 9.5 g/100g
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 67676-009-01 Natural Mineral Sunscreen 100 g in 1 BOTTLE, PUMP LOTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67676-009 NATURAL MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SARATI INTERNATIONAL, INC.] 1 Current NDC, 1 package rows 20240917_16ef922d-78d1-1e70-e063-6394a90a3bbf.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 67676-009-01 67676000901 100 g in 1 BOTTLE, PUMP (67676-009-01) 100 g 2024-09-16 No No Current