Otc - Active Ingredient
Homosalate 7.3%
Octisalate 4.9%
Octocrylene 9.9%
Zinc Oxide 7.04%
Dewytree Urban Shade Invisible Smoothing Pore Sunstic Sunstick
FDA Label NDC 73071-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dewytree Co. ,ltd for the product Dewytree Urban Shade Invisible Smoothing Pore Sunstic Sunstick (NDC 73071-102). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, otc - 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
Otc - Purpose
Sunscreen
Indications & 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.
Warnings
• For external use only.
Otc - Do Not Use
Do not use ■ on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if ■ rash occurs.
Otc - When Using
When using this product ■ keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure. ■ Reapply at least every 2 hours. ■ 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 10a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses.
Other Safety Information
■ protect this product in this container from excessive heat and direct sun.
Inactive Ingredient
Ethylhexyl Palmitate, Methyl Methacrylate Crosspolymer, Synthetic Wax, Vinyl Dimethi cone/Methicone Silsesquiox ane Crosspolymer, Caprylic/ Capric Triglyceride, Dibutyl Adipate, Butyloctyl Salicylat e, Crambe Abyssinica Seed Oil, 1,2-Hexanediol, Alpha-Bi sabolol, Polyhydroxystearic Acid, Polyglyceryl-4 Oleate, Pyrus Communis (Pear) Fruit Extract, Triethoxycaprylylsil ane, Tocopherol, Polyglycer yl-6 Oleate, Rosa Damascena Flower Water, Ethylhexylgly cerin, Iris Florentina Root Ex tract, Cucumis Melo (Melon) Fruit Extract, Hedera Helix (I vy) Leaf/Stem Extract, Beta -Carotene, Xanthophylls, Ro smarinus Officinalis (Rosema ry) Leaf Extract, Water, Glyc erin, Calamine, Butylene Gly col, Polyglyceryl-10 Myristat e, Hydrolyzed Extensin, Pot assium Cetyl Phosphate, Co cos Nucifera (Coconut) Oil, Methylpropanediol, Glycer yl Undecylenate, Coco-Cap rylate/Caprate, Copper T ripeptide-1, Palmitoyl Tetra peptide-7, Palmitoyl Tripep tide-1, Niacinamide, Sodium Ascorbyl Phosphate, Folic Acid, Thiamine HCl, Ribofla vin, Pyridoxine, Cyanocoba lamin, Biotin, Ascorbic Acid, Lactobacillus Ferment Ly sate, Lithospermum Erythro rhizon Root Extract, Chamo milla Recutita (Matricaria) Flower Oil, Helianthus Ann uus (Sunflower) Seed Oil
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