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| Product NDC Code | 84749-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Lino |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Lino Cosmetics 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 Ingredient Zinc Oxide 24.00%
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.Direction Directions Apply generously and evenly 15 minutes before sun exposure Not suitable for children apply to all skin exposed to the sun Reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Apply using your hands, blending into the top half of your arm, then forearm, upper leg and then lower leg, ensuring you are covering all skin. Use more product if needed. This product includes a gradual tan, therefore, please wash hands after use as product may stain.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Ascorbyl Tetraisopalmitate Butyloctyl Salicylate C13-15 Alkane Caprylyl Glycol Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone Dimethicone Ethylhexylglycerin Glycerin Green Tea Extract Isopropyl Myristate Niacinamide Pentylene Glycol Phenoxyethanol Polyhydroxystearic acid Propanediol Silica Sodium Chloride Sodium Phytate Sorbitan Olivate Synthetic Beeswax Water
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.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.
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.LINO Zinc Oxide BUTYLOCTYL SALICYLATE GLYCERIN NIACINAMIDE SODIUM CHLORIDE SODIUM PHYTATE GREEN TEA LEAF ALOE VERA LEAF CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN ASCORBYL TETRAISOPALMITATE PHENOXYETHANOL SILICA SORBITAN OLIVATE C13-15 ALKANE CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (950 MM2/S) WATER ZINC OXIDE ZINC OXIDE DIMETHICONE ISOPROPYL MYRISTATE PROPANEDIOL SYNTHETIC BEESWAX PENTYLENE GLYCOL
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.LINO SPF 50 LINO
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not use on damaged or broken skin.
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 If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll free 1-888-942-2887
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 Stop use and ask a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product When using this product keep out of eyes. Rinse with water to remove.
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.
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