MINERAL SHAKE- zinc oxide lotion

Mineral Shake by

Drug Labeling and Warnings

Mineral Shake by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings

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

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

Keep out of reach of children

Purpose

Sunscreen

Inactives

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

INGREDIENTS AND APPEARANCE

MINERAL SHAKE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-014-60	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2024
2	NDC: 80641-014-75	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/07/2024

Labeler - Vacation Inc. (117644631)