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| Product NDC Code | 61354-025 | ||||
|---|---|---|---|---|---|
| Drug Name | Cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Oxygen Development | ||||
| 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 Octinoxate 7.5 Oxybenzone 2.0
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 and blend evenly onto the face. Use over Studiomakeup soft illusion Face Primer for a flawless and smooth finish
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredients Water/Aqua, phenyl trimethicone, ethylhexyl methoxycinnamate, dimethicone, dicaprylyl ether, boron nitride, benzophenone-3, polymethylsilsesquioxane, silica, mica, aloe barbadensis leaf juice, disteardimonium hectorite, phenoxyethanol, dimethicone/PEG-10/15 crosspolymer, isododecane, sodium chloride, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, propylene carbonate, dimethicone crosspolymer, polyethylene, polysilicone-11, ethylhexyglycerin, aluminum dimyristate, triehoxycaprylylsilane,disodium stearoyl glutamate, disodium EDTA, citric acid, potassium sorbate, sodium benzoate, sodium hyaluronate. May contain [+/-]: titanium dioxide CI 77891, iron oxides CI 77491/ CI 77492/ CI 77499
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. Provides moderate protection against sunburn.
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.cream Octinoxate, Oxybenzone DIMETHICONE PHENYL TRIMETHICONE SODIUM CHLORIDE SILICON DIOXIDE OXYBENZONE OXYBENZONE PHENOXYETHANOL ALOE VERA LEAF WATER OCTINOXATE OCTINOXATE ISODODECANE DIMETHICONE/PEG-10/15 CROSSPOLYMER DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) MICA DICAPRYLYL ETHER BORON NITRIDE
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 61354-021-01_AW 61354-021-01_AW 61354-021-01_AW 61354-021-01_AW
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