FDA.reportPublic FDA data

Mineral Shake

Product NDC
80641-014
11-digit product format
806410014
Labeler code
80641
Product ID
80641-014_138cbcd0-ac5c-4e14-e063-6394a90af42c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
Substance
ZINC OXIDE
Active strength
20.5 g/100mL
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
Mineral Shake
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
131b7e65-7155-f925-e063-6394a90a1d7aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-014-60Mineral Shake15 mL in 1 BOTTLELOTION153
80641-014-75Mineral Shake50 mL in 1 BOTTLELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-014MINERAL SHAKE (ZINC OXIDE) LOTION [VACATION INC.]3Current NDC, 2 package rows20240315_131b7e65-7155-f925-e063-6394a90a1d7a.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 136 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d9c77-ed9f-a518-e063-6394a90a34fa2025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374e2294-7281-c7b9-e063-6394a90acc892025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
application number: M020
Non - Tinted Mineral SunscreenZINC OXIDENEXTEX CORPORATION35bacfcf-0254-aa0a-e063-6394a90a14752025-12-11Exact identifier
application number: M020
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
application number: M020
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
application number: M020
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
application number: M020
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
application number: M020
flawless photo finishZINC OXIDENEXTEX CORPORATION35bb0ac4-6abd-ca75-e063-6394a90a26cd2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
application number: M020
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
application number: M020
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incroporated352fe5e4-8b3f-248f-e063-6394a90ab42c2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incorporated3530898c-7bdf-6ffe-e063-6394a90aa0372025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-014-608064100146015 mL in 1 BOTTLE (80641-014-60) 15 ml2024-03-07NoNoCurrent
80641-014-758064100147550 mL in 1 BOTTLE (80641-014-75) 50 ml2024-03-07NoNoCurrent