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| Product NDC Code | 84426-001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Invisible sunscreen spf 40 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | PARTICLE AESTHETIC SCIENCE LTD | ||||||||
| 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 Homosalate 10% Octisalate 5% Avobenzone 3% Octocrylene 2.6%
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 Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours 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 value of 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate
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 ) decrease the risk of skin cancer and early skin aging damaged 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.Invisible Sunscreen SPF 40 Homosalate, Octisalate, Avobenzone, Octocrylene HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SODIUM BENZOATE OCTOCRYLENE OCTOCRYLENE PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER DIMETHYL ISOSORBIDE ISOMALT WATER AVOBENZONE AVOBENZONE ETHYLHEXYL PALMITATE .ALPHA.-TOCOPHEROL ACETATE CAPRYLYL TRISILOXANE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TOCOPHEROL ISODODECANE BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES LECITHIN, SUNFLOWER SILICON DIOXIDE DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER SESAME SEED VITIS VINIFERA FRUIT RIND
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.Secondary
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 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. 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 Other information Protect this product from excessive heat and direct sun
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
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 you use 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 Do not use on damaged or broken skin When you use 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