Tan Smart Mineral Sunscreen

Tan Smart Mineral Sunscreen by

Drug Labeling and Warnings

Tan Smart Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TAN SMART MINERAL SUNSCREEN- sunscreen lotion 
I Shay Cosmetics Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tan Smart Mineral Sunscreen

Zinc Oxide 15.6% ... Sunscreen

Sunscreen

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.

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.

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.

- 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

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	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019	04/01/2021

Labeler - I Shay Cosmetics Inc (151582384)

Revised: 10/2021

Document Id: ce54264b-5794-08ea-e053-2995a90a2438

34390-5

Set id: b9e512e3-833a-1f44-e053-2a95a90a7fcb

Version: 2

Effective Time: 20211014