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Drug Facts
Sulwhasoo Uv Wise On-the-go Sun Cushion Lotion
FDA Label NDC 43419-094
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amorepacific Corporation for the product Sulwhasoo Uv Wise On-the-go Sun Cushion (NDC 43419-094). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate 3%
Octinoxate 6.49545%
Octisalate 3%
Titanium Dioxide 3.661%
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
Otc - Do Not Use
- Do not use on broken skin.
Otc - When Using
- When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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. If swallowed, call a poison control centre or get medical help right away.
Directions
◼ Apply liberally 15 minutes before sun exposure.
◼ Children under 6 months of age : Ask a doctor.
◼ Reapply at least every 2 hours.
◼ Use a water-resistant sunscreen if swimming or sweating.
◼
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 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water / Aqua / Eau, Methyl Trimethicone, Diphenylsiloxy Phenyl Trimethicone, Ethylhexyl Methoxycrylene, Butylene Glycol, Silica, Polyglyceryl-3 Polyricinoleate, 1,2-Hexanediol, Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Sodium Chloride, VP/Hexadecene Copolymer, Caprylyl Glycol, Fragrance / Parfum, Glyceryl Caprylate, Ethylhexylglycerin, Limonene, Morus Alba Root Extract, Linalool, Morus Alba Leaf Extract, Squalane, Propanediol, Panax Ginseng Root Extract, Citronellol, BHT, Citral, Rehmannia Glutinosa Root Extract, Sodium Hyaluronate, Geraniol, Paeonia Lactiflora Root Extract, Polygonatum Odoratum Rhizome Extract, Nelumbo Nucifera Flower Extract, Benzyl Benzoate, Lilium Tigrinum Bulb Extract, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate Crosspolymer, Tocopherol, Hyaluronic Acid, Sodium Acetylated Hyaluronate
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