TAN SMART MINERAL SUNSCREEN- sunscreen lotion

Sunplus Sunscreen Yosemite SPF 45 by

Drug Labeling and Warnings

Sunplus Sunscreen Yosemite SPF 45 by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 15.6% ... Sunscreen

PURPOSE

Sunscreen

WARNINGS

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

INDICATIONS & USAGE

Helps prevent sunburn

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

INACTIVE INGREDIENT

Purified Water, Coco-Caprylate/Caprate(and)Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Glycerin, Butylene Glycol, Acetyl Tyrosine, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Riboflavin, Butyrospermum Parkii Butter, Hippophae Rhamnoides Seed Oil, Terminalia Ferdinandiana Seed Oil, Caryodendron Orinocense Seed Oil, Palmitic Acid, Stearic Acid, Calophyllum Tacamahaca Seed Oil, Orbignya Oleifera Seed Oil, Cocos Nucifera Oil, Theobroma Grandiflorum Seed Butter, Astrocaryum Murumuru Seed Butter, Gardenia Taitensis Flower Extract, Tocopherol, Hippophae Rhamnoides Fruit Oil, Cetearyl Alcohol, Ceteareth 20, Glyceryl Stearate, PEG-100 Stearate, Isononyl Isononoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Ethylhexyl Palmitate, Cetyl Alcohol, Isoamyl Stearate, Bisabolol, Glycine Soja Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethiconol, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

DOSAGE & ADMINISTRATION

- Apply liberally and evenly 15 minutes before sun exposure.

- Children under 6 months of age: Ask a doctor.

- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

-- Limit time in the sun especially from 10 am - 2 pm.

-- Wear long-sleeved shirts, pants, hats, and sunglasses

-- Reapply after 80 minutes of swimming or seating:

---- Immediately after towel drying

---- At least every 2 hours

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TAN SMART MINERAL SUNSCREEN 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.15 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.8 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-255-01	4347 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - I. Shay Cosmetics (151582384)