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| Product NDC Code | 60232-3537 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Image md restoring lip enhancer spf15 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Swiss-American CDMO, LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3.0% Sunscreen Homosalate 10.0% Sunscreen Octisalate 5.0% Sunscreen Octocrylene 4.0% Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Directions 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.
Purpose
Information about the drug product’s indications for use.Indications & Usage 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.
Spl product data elements
Usually a list of ingredients in a drug product.Image MD Restoring Lip Enhancer SPF15 sunscreen OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE PENTAERYTHRITYL TETRAISOSTEARATE PPG-12/SMDI COPOLYMER ETHYLHEXYL PALMITATE LIMONENE, (+)- TRIBEHENIN PHENYL TRIMETHICONE SORBITAN ISOSTEARATE SILICA DIMETHYL SILYLATE BUTYLENE GLYCOL PENTYLENE GLYCOL LACTIC ACID LINALOOL, (+)- SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) CITRAL PALMITOYL TRIPEPTIDE-1 AVOCADO OIL .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL HYDROGENATED POLYBUTENE (1300 MW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) DIISOPROPYL DILINOLEATE ORYZANOL UBIDECARENONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Labeling Image Lip Enhancer UC
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children Keep out of reach of children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Questions call 800-796-7546
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API