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 143 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC31416d04-2d6f-7cf9-e063-6294a90a98062025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143968a-096e-b9ac-e063-6294a90ada0d2025-12-09WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC314299b1-a78b-c1bd-e063-6294a90ab43b2025-12-09WarningsExact identifier
application number: M020
Sheer Satin Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143d8b0-4af8-f52d-e063-6294a90a926b2025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3142ed0f-f379-f240-e063-6294a90a53032025-12-09WarningsExact identifier
application number: M020
Sheer Non-Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33d83cfb-045d-141c-e063-6394a90a2e042025-12-09Exact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company45875865-5e9c-d652-e063-6394a90ad5fa2025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
application number: M020
Transparent Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33dbfd9b-b90f-bb32-e063-6294a90af7dc2025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact identifier
application number: M020
ReplenishZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316c43fb-0c15-87d4-e063-6294a90a0a632025-12-09Exact identifier
application number: M020
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesece7565b-f3e5-3386-e053-2a95a90a58022025-12-09WarningsExact identifier
application number: M020
Hydraboost Lip TreatmentAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBluemercury2cf30083-8723-23f6-e063-6394a90a55de2025-12-09WarningsExact identifier
application number: M020
Florida Babe Sport Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4756d-8604-6e75-e063-6294a90aebe12025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4d9ae-f532-f9f5-e063-6294a90a8d392025-12-09Exact identifier
application number: M020
Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEArbonne International, LLC91bcd120-28e5-4f44-9522-550c1dbcd82c2025-12-09WarningsExact identifier
application number: M020
Florida Babe Active Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e509f2-dcb6-5ae0-e063-6394a90a70c12025-12-09Exact identifier
application number: M020
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e57817-b8c4-8178-e063-6294a90a01492025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA3231f1fe-51b3-b2e7-e063-6394a90a27582025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA31e63876-3e39-adc6-e063-6394a90ab1462025-12-09Exact 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