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 185 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN2ZINC OXIDEPUR Minerals3f06ed2f-f43f-53d4-e063-6294a90af0dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN4ZINC OXIDEPUR Minerals3f06f618-f7b2-53d0-e063-6294a90a829c2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN3ZINC OXIDEPUR Minerals3f06df49-5ed2-44ca-e063-6294a90a1fda2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LN2ZINC OXIDEPUR Minerals3f069dfe-289d-8d3b-e063-6394a90a04962025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LG3ZINC OXIDEPUR Minerals3f06ec3e-fc15-9f7b-e063-6394a90a07332025-09-24WarningsExact identifier
application number: M020
Volition Prismatic Luminizing ShieldZINC OXIDEVolition1a633c24-b9d9-4732-e063-6294a90af4c02025-09-24WarningsExact identifier
application number: M020
Alleyoop Sunsational Broad SpectrumZINC OXIDENewAlley Innovations Inc248419c4-8044-402c-e063-6394a90a00f82025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 30 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%Aloe Upf7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e922025-09-24WarningsExact identifier
application number: M020
pavise Dynamic Age DefenseZINC OXIDEB.A.I BIOSCIENCES, INCf4e9f95c-6b1e-d5f7-e053-2a95a90a93ce2025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 50 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%Aloe Upd535b711-c54e-4447-9907-ca9d829d13192025-09-24WarningsExact identifier
application number: M020
ESPOIR WATER SPLASH SUN SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEESPOIR Corporation1c4e7ba2-05e8-f949-e063-6394a90a699d2025-09-23WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1d11c3d0-5f4e-0ed0-e063-6294a90abc752025-09-23WarningsExact identifier
application number: M020
Dewscreen Daily Hydrator and Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7c84e3-0e4f-b7e9-e063-6294a90a12952025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15d8574d-94bb-4842-e063-6394a90a15e62025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15da0cb1-e695-cec3-e063-6394a90a1afa2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15daac41-54b6-096d-e063-6294a90a07362025-09-23WarningsExact identifier
application number: M020
Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50ZINC OXIDESun Bum, LLC3f8101b1-297d-2ad8-e063-6294a90a9cff2025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESun Bum, LLC20c48752-3ad9-5993-e063-6294a90ae1b02025-09-23WarningsExact 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