Active Ingredients
Zinc Oxide 12%
Clean Tinted
FDA Label NDC 72394-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clean, Know What's On Your Skin Llc for the product Clean Tinted (NDC 72394-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose:, uses, warnings, do not use, when using this product:, stop use and ask doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Sunscreen
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
Warnings
For external use only
Do Not Use
on damaged or broken skin
When Using This Product:
keep out of the eyes. Rinse with water to remove.
Stop Use And Ask Doctor
is skin rash occurs
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• Immediately after towel drying
• at least every two hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: ask a Doctor
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C16 Alpha Olefin, Capryl Glycol, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract*, Citrus Aurantium Dulcis (Orange) Fruit Extract*, Citrus Aurantium Dulcis (Orange) Peel Extract*, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Glycerin*,Hexylene Glycol, Iron Oxides, Isododecane, Oenothera Biennis (Evening Primrose) Oil*, Palmaria Palmata Extract, Phenoxyethanol, Propanediol, Rosa Canina Fruit Oil*, Sodium Chloride, Tetrasodium Glutamate Diacetate, Tocopherol, Triethoxycaprylylsilane, Trilaureth-4 Phosphate, VP/ Eicosene Copolymer, Water, Zostera Marina Extract *=Organic
Other Information
• protect this product from excessive heat and direct sun
Questions Or Comments?
Call 424-272-6522
Clean Tinted Lotion, 50Ml (72394-000-00)
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