Home NDC 83081-2045 Sand Cloud Mineral Sunscreen
Product NDC 83081-2045
11-digit product format 830812045
Labeler code 83081
Product ID 83081-2045_4655b7b6-125c-ad40-e063-6294a90a48ce
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Sand Cloud Holdings, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-30
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 54; 108 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 Sand Cloud Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 54 mg/mL ZINC OXIDE 108 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83081-2045-3 Sand Cloud Mineral Sunscreen 89 mL in 1 TUBE LOTION 89 3 83081-2045-5 Sand Cloud Mineral Sunscreen 148 mL in 1 TUBE LOTION 148 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83081-2045 SAND CLOUD MINERAL SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SAND CLOUD HOLDINGS, LLC] 2 Current NDC, 2 package rows 20231207_ff477199-9b01-fc90-e053-6294a90a5102.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 81 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 83081-2045-3 83081204503 89 mL in 1 TUBE (83081-2045-3) 89 ml 2023-06-30 No No Current 83081-2045-5 83081204505 148 mL in 1 TUBE 148 ml Historical