Mineral Shake

Manufacturer
Vacation Inc.
Effective date
2024-03-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:42

Label at a glance#

ProductMineral Shake
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating

Label contents#

Full prescribing information#

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinsed with water to remove.

Stop use and ask a doctor is rash occurs

Indications and Usage

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Sunscreen

Inactives

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP

Cholesterol, Cucumis Sativus (Cucumber) Fruit Extract, Dihydro Myrcenol, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexyl Olivate, Ethylhexylglycerin, Ferulic Acid, Floralozone, Glycerin, Gossypium Herbaceum (Cotton) Seed Oil, Hexyl Cinnamic Aldehyde, Hyaluronic Acid, Isododecane, Magnesium Sulfate, Methyl Octyne Carbonate, Niacinamide, Passiflora Edulis Seed Oil, Phenoxyethanol, Phytosphingosine, Polyglyceryl-3 Oleate

Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Scentenal, Sodium Benzoate, Sodium Gluconate, Sodium Lauroyl Lactylate, Squalane, sr-Hydrozoan Polypeptide-1, Tocopherol, Triethoxycaprylylsilane

Undecavertol, Water, Xanthan Gum

Vacation SPF 50 Mineral Shake

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral ShakeMineral Shake

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80641-01480641-014-60, 80641-014-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral ShakeZINC OXIDEVacation Inc.131b7e65-7155-f925-e063-6394a90a1d7a2024-03-13WarningsExact identifier
ndc (package): 80641-014-60
ndc (package): 80641-014-75
ndc (product): 80641-014
ndc11 (package): 80641001460
ndc11 (package): 80641001475
spl id: 138cbcd0-ac5c-4e14-e063-6394a90af42c
spl set id: 131b7e65-7155-f925-e063-6394a90a1d7a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.