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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83081-204583081-2045-5DDiscontinued by firm2026-10-23

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
IngredientStrength
TITANIUM DIOXIDE54 mg/mL
ZINC OXIDE108 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff477199-9b01-fc90-e053-6294a90a5102Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83081-2045-3Sand Cloud Mineral Sunscreen89 mL in 1 TUBELOTION893
83081-2045-5Sand Cloud Mineral Sunscreen148 mL in 1 TUBELOTION1483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83081-2045SAND CLOUD MINERAL SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [SAND CLOUD HOLDINGS, LLC]2Current NDC, 2 package rows20231207_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 127 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
application number: M020
WOODSLEEP Sunscreen BalmTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.45cfc7ed-34a6-1f45-e063-6394a90a902b2025-12-13WarningsExact identifier
application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50ZINC OXIDE 24%UNIVERSKIN45d242de-cbd8-e7ea-e063-6394a90aaebf2025-12-13WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50ALAINA HEALTHCARE PRIVATE LIMITEDb7847d4f-2517-4b58-8e31-676c9d6e484d2025-12-12WarningsExact identifier
application number: M020
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
application number: M020
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC40323dfa-29e4-1464-e063-6294a90aa65c2025-12-12WarningsExact identifier
application number: M020
Zinc 20Percent SPF 40ZINC OXIDEJOHANNA'S SKIN CARE3545ed3e-b42f-d29d-e063-6394a90a8efe2025-12-12Exact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032f0b0-c083-d227-e063-6394a90a30682025-12-12WarningsExact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396d952b-22ff-567f-e063-6394a90a8c682025-12-12Exact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396dfc9c-b6c0-5892-e063-6394a90a110c2025-12-12Exact identifier
application number: M020
KawaKids KawaSun - Premium Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f41f64b-d707-08e2-e063-6294a90aa9242025-12-12WarningsExact identifier
application number: M020
KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f4341f7-b499-3b73-e063-6394a90a75b82025-12-12WarningsExact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f7f72-c426-e42f-e063-6294a90a4b3a2025-12-12Exact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f06f3-9deb-4c1a-e063-6394a90ad7662025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352d72f6-06b9-6fdc-e063-6294a90ab4482025-12-12Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83081-2045-38308120450389 mL in 1 TUBE (83081-2045-3) 89 ml2023-06-30NoNoCurrent
83081-2045-583081204505148 mL in 1 TUBE148 mlHistorical