The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Image Md Restoring Lip Enhancer Spf15 (NDC 60232-3537). 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 warnings, active ingredients, indications & usage, keep out of reach of children, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 4.0% Sunscreen
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Keep out of reach of children
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
Protect the product in this container from excessive heat and direct sun.
hydrogenated polyisobutene, ethylene/propylene/styrene copolymer, Pentaerythrityl Tetraisostearate, ethylhexyl palmitate, PPG-12/SMDI Copolymer, butylene/ethylene/styrene copolymer, flavor, limonene, tribehenin, phenyl trimethicone, sorbitan isostearate, silican dimethyl silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, butylene glycol, pentylene glycol, lactic acid, linalool, sodium chondrotin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, Avacodo (Persea gratissima) Oil, Diisopropyl Dimer Dilinoleate, Tocopheryl Acetate, Tocopherol, Oryzanol, Ubiquinone.
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