Indications & Usage
Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun
Poutscreen Lip Treatment Tiramisu Liquid
FDA Label NDC 81104-605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naked Sundays Pty Ltd for the product Poutscreen Lip Treatment Tiramisu (NDC 81104-605). 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 indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warnings: For external use only.
• 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: If product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions:
• Apply liberally and evenly 15 minutes before sun exposure.
• Re-apply at least every 80 minutes or immediately after swimming, sweating or towel drying.
• Use a water-resistant sunscreen if swimming or sweating.
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 10.00AM - 2.00PM
• Wear long-sleeved shirts, pants, hats, and sunglasses
Other Safety Information
Other Information:
• Protect this product from excess heat and direct sun.
• Store below 30°C / 86°F
Questions:
Otc - Purpose
Sunscreen
Inactive Ingredient
Trimasu:
Water, Polybutene (1400 MW), Isopropyl Myristate, Caprylic/Capric Triglyceride, Octyldodecanol, Squalane, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Pentaerythrityl Tetraisostearate, Ethylhexyl Methoxycrylene, Sorbitan Oleate, Stearalkonium Hectorite, Propylene Carbonate, Silica Dimethyl Silylate, Behenyl Acrylate Polymer, Polyglutamic Acid (1200 MW), Palmitoyl Hexapeptide-12, Solanum Lycopersicum (Tomato) Fruit Extract, Sucralose, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 (CI 19140).
Chocolate Kiss:
Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491, CI 19140, CI 77499.
Lemon Meringue:
Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491.
Package Label.Principal Display Panel
L (Lemon)
V (Tiramisu)
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