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| Product NDC Code | 64141-025 | ||||||||
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| Drug Name | Skin long-wear weightless foundation broad spectrum spf 15 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Bobbi Brown Professional Cosmetics Inc. | ||||||||
| 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 Octinoxate 3.0% Titanium Dioxide 1.6%
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 suncreen use: apply liberally 15 minutes before sun exposure reapply at least 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 suncreen 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 • dimethicone • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • butylene glycol • glycerin • disteardimonium hectorite • polyglyceryl-3 diisostearate • sodium chloride • laminaria saccharina extract • butyrospermum parkii (shea butter) • fragrance (parfum) • ascorbyl palmitate • tocopherol • dimethicone crosspolymer • methicone • stearic acid • tocopheryl acetate • glyceryl oleate • lecithin • glyceryl stearate • citric acid • aluminum hydroxide • talc • disodium edta • linalool • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln44078>
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.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE WATER DIMETHICONE BUTYLENE GLYCOL GLYCERIN DISTEARDIMONIUM HECTORITE POLYGLYCERYL-3 DIISOSTEARATE SODIUM CHLORIDE SACCHARINA LATISSIMA SHEA BUTTER ASCORBYL PALMITATE TOCOPHEROL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) METHICONE (20 CST) STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE GLYCERYL OLEATE GLYCERYL MONOSTEARATE CITRIC ACID MONOHYDRATE ALUMINUM HYDROXIDE TALC EDETATE DISODIUM ANHYDROUS LINALOOL, (+/-)- SODIUM DEHYDROACETATE PHENOXYETHANOL MICA FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC 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 - 30 ml Bottle Carton BOBBI BROWN Skin Long-Wear Weightless Foundation Broad Spectrum SPF 15 Full Cover Oil-Free Shine Control 1 FL. OZ./30 ml e PRINCIPAL DISPLAY PANEL - 30 ml Bottle 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
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