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 firm2026-10-20

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 93 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60183a47-fd02-052b-e053-2991aa0a1b5c2025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and NectarZINC OXIDEThe Procter & Gamble Manufacturing Company026dcaee-d33c-b874-e063-6394a90ad2e72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ab56-abaa-42de-e063-6394a90a63102025-12-31WarningsExact identifier
application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company22f645cf-5182-9e3f-e063-6394a90adc842025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical BreezeZINC OXIDEThe Procter & Gamble Manufacturing Company232032b7-803f-40ec-e063-6394a90a4b382025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince1a9a831-a0b9-17ba-e053-2a95a90a3fa72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ebec-acb0-77c4-e063-6394a90aee072025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08134b95-1879-27e5-e063-6294a90a29af2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incded1f158-36d1-153f-e053-2995a90ace302025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08147940-0e8b-c894-e063-6394a90af8ac2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince468d703-fa6c-095a-e053-2a95a90a51942025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPL 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incdf4b522e-93d4-1284-e053-2a95a90a1cd92025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a40ff-a014-3995-e063-6394a90a11e62025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Ince451ecfb-cf17-c622-e053-2a95a90a4d4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact 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