Otc - Active Ingredient
Octocrylene 9.00%
Homosalate 7.30%
Octisalate 4.90%
Avobenzone 2.90%
Dewyvita Zero Spot Sunscreen Cream
FDA Label NDC 87350-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bareunplan Co.,ltd. for the product Dewyvita Zero Spot Sunscreen (NDC 87350-100). 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 - when using, otc - stop use, 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 preven 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 - When Using
When using this product ■ keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if ■ rash occurs.
Otc - Keep Out Of Reach Of Children
■ keep out of reach of children.
Dosage & Administration
■ Apply liberally 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 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 a.m.-2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating
Inactive Ingredient
Water/Aqua, Butyloctyl Salicylate, Dipropylene Glycol, Silica, Nia cinamide, Diphenylsiloxy Phenyl Trimethicone, Sorbitan Olivate, Benzyl Glycol, Cetearyl Glucoside, Polymethylsilsesquioxane, Poly C10-30 Alkyl Acrylate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Cetearyl Alcohol, Ethylhexylglycerin, Adenosine, Centella Asiatica Extract, Rosa Damascena Flower Extract, Lactobacillus Ferment, Leontopodium Alpinum Callus Culture Extract, Butylene Glycol, Punica Granatum Fruit Extract, Madecassoside, 1,2-Hexanediol, Glycerin, Camellia Sinensis Leaf Water, Glutathione, Asiaticoside, Ethyl Hexanediol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Madecassic Acid, Sodium Hyaluronate, Asiatic Acid, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Caprylyl Glycol, Sodium Hyaluronate DimethyIsilanol, Sodium Acetylated Hyaluronate
Other Safety Information
■ protect the product in this container from excessive heat and direct sun.
* Please review the disclaimer below.
