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Product NDC Code | 10967-670 | ||||
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Drug Name | Prevage city smart |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
Application Number | M020 | ||||
Labeler Name | REVLON | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS TITANIUM DIOXIDE 6.2% W/W.................Sunscreen ZINC OXIDE 5.6% W/W ............................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.As needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).
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.Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.PREVAGE CITY SMART TITANIUM DIOXIDE, ZINC OXIDE ARABIDOPSIS THALIANA WHOLE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PHENOXYETHANOL LINALOOL, (+/-)- DIMETHICONE ALKYL (C12-15) BENZOATE ZINC OXIDE ZINC OXIDE CAPRYLYL TRISILOXANE ISOMETHYL-.ALPHA.-IONONE FERRIC OXIDE RED LECITHIN, SOYBEAN MICA PEG/PPG-18/18 DIMETHICONE SODIUM PYRROLIDONE CARBOXYLATE WATER HYDROGEN DIMETHICONE (20 CST) HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE CYCLOMETHICONE 5 PENTYLENE GLYCOL BUTYLENE GLYCOL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) GREEN TEA LEAF CAPRYLYL GLYCOL EDETATE DISODIUM ANHYDROUS ERGOTHIONEINE CARNOSINE ISOPROPYL MYRISTATE SILICA DIMETHYL SILYLATE FERULIC ACID STANNIC OXIDE .ALPHA.-TOCOPHEROL ACETATE TITANIUM DIOXIDE TITANIUM DIOXIDE GLYCERIN ALUMINUM HYDROXIDE CHLORPHENESIN FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ISODODECANE STEARIC ACID
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.CARTON ART prvg city art
Instructions for use
Information about safe handling and use of the drug product.USES ■ Helps prevent sunburn ■ If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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.
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.DIRECTIONS FOR SUNSCREEN USE Directions For Sunscreen Use: ■ Apply liberally 15 minutes before sun exposure ■ Reapply: at least every 2 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 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-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months: Ask a doctor
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION ■ Protect this product from excessive heat and direct ■ Store at room temperature
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 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