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| Product NDC Code | 69435-1411 | ||||
|---|---|---|---|---|---|
| Drug Name | Fre plump me peptide lip tint cassis spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide 15%
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.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Polybutene, Butyrospermum Parkii (Shea) Butter, Butyloctyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Rapeseed Oil, Isodecyl Neopentanoate, Argania Spinosa Kernel Oil, C10-18 Triglyceride, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Water, Citrus Aurantium Dulcis Peel Oil, Citrus Limon (Lemon) Peel Oil, Glycerin, Argania Spinosa Leaf Extract, Argania Spinosa Callus Culture Extract, Isomalt, Lecithin, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Portulaca Pilosa Extract, Sucrose Cocoate, Palmitoyl Tripeptide-38, Alcohol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Blue 1 Lake (CI 42090), Tin Oxide (CI 77861).
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. • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying. • 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 value of 15 or higher and other sun protection measures. • Limit time in the sun, especially from 10 a.m.- 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • For children under 6 months of age: Ask a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30 ZINC OXIDE CI 77491 CI 77492 CI 42090 LECITHIN, SUNFLOWER ALCOHOL GLYCERIN ARGANIA SPINOSA LEAF CETEARYL ETHYLHEXANOATE CITRUS LIMON (LEMON) PEEL OIL SHEA BUTTER CASTOR OIL CANDELILLA WAX POLYHYDROXYSTEARIC ACID (2300 MW) CI 77499 TIN OXIDE ZINC OXIDE ZINC OXIDE C10-18 TRIGLYCERIDES WATER CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL ARGAN OIL PORTULACA PILOSA WHOLE SUCROSE COCOATE ISODECYL NEOPENTANOATE CAPRYLIC/CAPRIC TRIGLYCERIDE BUTYLOCTYL SALICYLATE TRIETHOXYCAPRYLYLSILANE SORBITAN ISOSTEARATE POLYBUTENE (1400 MW) HYDROGENATED RAPESEED OIL ISOMALT PALMITOYL TRIPEPTIDE-38
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.Product Labeling FRE CASSIS
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 If swallowed, get medical help or contact a Poison Control Center right away.
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 & Comments Call toll free 1-888-589-6243
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
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 a doctor if rash occurs. Keep out of reach of children 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