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| Product NDC Code | 61354-040 | ||
|---|---|---|---|
| Drug Name | Foundation |
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| Type | Brand | ||
| Active Ingredients |
|
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| Route | TOPICAL | ||
| Dosage Form | EMULSION | ||
| Application Number | part352 | ||
| Labeler Name | Oxygen Development LLC | ||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Medicinal Ingredient / Active Ingredient Octinoxate 5.0% w/w
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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: 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 10am to 2 pm Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non-medicinal Ingredients / Inactive Ingredients Aqua, Cyclopentasiloxane, Propanediol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone,Trimethylsiloxysilicate, Boron Nitride, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Ethylhexanoate, Magnesium Sulfate, Silica Silylate, Zinc Stearate, Phenoxyethanol, Mannitol, Bis-PEG/PPG-14/14 Dimethicone, Laureth-7, Amodimethicone, Lecithin, Tribehenin, Butyrospermum Parkii (Shea) Butter Extract, Sodium Starch Octenylsuccinate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disteardimonium Hectorite, Glucosamine HCl, Trihydroxystearin, Dimethiconol, Triethoxycaprylylsilane, Pisum Sativum (Pea) Extract, Xanthan Gum, Bambusa Vulgaris Leaf/Stem Extract, Hydroxyethylcellulose, Tocopheryl Acetate, Ethylhexylglycerin, Propylene Carbonate, Sodium Gluconate, Pentylene Glycol, Lactic Acid, Citric Acid, Sodium Citrate, Dextrin, Retinol, Waltheria Indica Leaf Extract, Ferulic Acid, EDTA, Ceramide AP, May Contain: Mica, 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.
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.Foundation Octinoxate SILICA DIMETHYL SILYLATE STARCH, CORN OCTINOXATE OCTINOXATE WATER C12-15 ALKYL ETHYLHEXANOATE MAGNESIUM SULFATE, UNSPECIFIED FORM TRIBEHENIN LECITHIN, SOYBEAN CYCLOMETHICONE 5 PROPANEDIOL SODIUM PYRROLIDONE CARBOXYLATE PHENOXYETHANOL TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER MANNITOL BIS-PEG/PPG-14/14 DIMETHICONE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) MICA BORON NITRIDE ZINC STEARATE LAURETH-7
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.Primary packaging 61354-040_AW 61354-040_AW
Secondary Packaging 61354-040-01_AW 61354-040-01_AW 61354-040-01_AW
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Protect this product from excessive heat and direct sun. In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.
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