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| Product NDC Code | 40046-0065 | ||||
|---|---|---|---|---|---|
| Drug Name | Studio sculpt spf 15 broad spectrum foundation |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | MAKEUP ART COSMETICS | ||||
| 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 Purpose Octinoxate 7.00% Sunscreen Titanium Dioxide 2.00% Sunscreen
| Octinoxate 7.00% | Sunscreen |
| Titanium Dioxide 2.00% | Sunscreen |
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 For sunscreen use: apply liberally 15 minutes before sun exposure reapply every two hours use a water resistant sunscreen if swimming or sweating 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 water\aqua\eau, cyclopentasiloxane, glycerin, butylene glycol, octyldodecyl neopentanoate, peg/ppg-18/18 dimethicone, polymethylsilsesquioxane, isostearic acid, c4-24 alkyl dimethicone/divinyldimethicone crosspolymer, isononyl isononanoate, tamarindus indica seed extract, tocopherol, tocopheryl acetate, sodium hyaluronate, haberlea rhodopensis leaf extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, butyrospermum parkii (shea butter), yeast extract\faex\extrait de levure, quercus suber bark extract, phytantriol, dextrin palmitate, dextrin palmitate/ethylhexanoate, cellulose gum, tetrahexyldecyl ascorbate, xanthan gum, dimethicone, methicone, propylene carbonate, sodium chloride, palmitic acid, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, polymethyl methacrylate, octyldodecyl pca, disteardimonium hectorite, stearic acid, caprylyl glycol, dipropylene glycol, phenoxyethanol, aluminum stearate, hexylene glycol [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln35219>
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.Use helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Active Ingredients Purpose Octinoxate 7.00% Sunscreen Titanium Dioxide 2.00% Sunscreen
| Octinoxate 7.00% | Sunscreen |
| Titanium Dioxide 2.00% | Sunscreen |
Spl product data elements
Usually a list of ingredients in a drug product.STUDIO SCULPT SPF 15 BROAD SPECTRUM FOUNDATION OCTINOXATE and TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 GLYCERIN BUTYLENE GLYCOL OCTYLDODECYL NEOPENTANOATE PEG/PPG-18/18 DIMETHICONE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ISOSTEARIC ACID ISONONYL ISONONANOATE TOCOPHEROL HYALURONATE SODIUM BEET SHEA BUTTER PHYTANTRIOL DEXTRIN PALMITATE (CORN; 20000 MW) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TETRAHEXYLDECYL ASCORBATE XANTHAN GUM DIMETHICONE METHICONE (20 CST) PROPYLENE CARBONATE SODIUM CHLORIDE PALMITIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE POLY(METHYL METHACRYLATE; 450000 MW) DISTEARDIMONIUM HECTORITE STEARIC ACID CAPRYLYL GLYCOL DIPROPYLENE GLYCOL PHENOXYETHANOL ALUMINUM STEARATE HEXYLENE GLYCOL MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE CHROMIC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton MAC STUDIO SCULPT SPF 15 FOUNDATION BROAD SPECTRUM SPF 15 40 ML/1.3 US FL OZ e PRINCIPAL DISPLAY PANEL - 40 ML Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
DIST. BY: MAKE-UP ART COSMETICS TORONTO, ONTARIO, CANADA M5V 1R7
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 product is 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
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 using 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 product is 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