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| Product NDC Code | 61354-047 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Oxygen Development, 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 Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 10%
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. Reapply at least every 2 hours. Sun protection meassures: Spending time in the sun increasses 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, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isododecane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, VP/Eicosene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate
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 another sun protection measures (see Directions), decreasses 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.Sunscreen Homosalate, Octocrylene, Octisalate, Avobenzone OCTISALATE OCTISALATE ISODODECANE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) VINYLPYRROLIDONE/EICOSENE COPOLYMER BUTYLOCTYL SALICYLATE HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ALUMINUM HEXAFLUOROSILICATE NONAHYDRATE OCTOCRYLENE OCTOCRYLENE
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.Package 61354-047-01_AW
Package 61354-047-02_AW
Package 61354-047-04_aw 61354-047-03_AW
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 damage or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rigth 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