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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 83081-2045 83081-2045-5 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
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 Identifiers# Field, Values table Field Values Unii 15FIX9V2JP, SOI2LOH54Z
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
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