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| Product NDC Code | 36800-093 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Topcare everyday ultimate sheer sun broad spectrum spf 70 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0% Homosalate 10.0% Octisalate 3.0% Octocrylene 7.0% Oxybenzone 6.0%
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 reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours children under 6 months of age: Ask a doctor 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, styrene/acrylates copolymer, dimethicone, acylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xanthan gum, capryl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA, fragrance
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.TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER EDETATE DISODIUM TRIDECETH-6 TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) XANTHAN GUM ETHYLHEXYL STEARATE CAPRYLYL TRISILOXANE DIMETHICONE WATER BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER SILICON DIOXIDE POLYSILICONE-15 GLYCERYL STEARATE/PEG-100 STEARATE SODIUM POLYACRYLATE (8000 MW) PROPYLENE GLYCOL GLYCYRRHIZINATE DIPOTASSIUM WHITE WAX ETHYLHEXYLGLYCERIN PHENOXYETHANOL CETYL DIMETHICONE 45 CAPRYLYL GLYCOL HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE OXYBENZONE OXYBENZONE
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.TopCare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 70 3.0 FL OZ (89 mL) -09 TOP45900A1
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.
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 using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information • protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces
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