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Product NDC Code | 73122-065 | ||||
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Drug Name | Rvr90 firm |
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Type | Brand | ||||
Dosage Form | KIT | ||||
Application Number | part352 | ||||
Labeler Name | Ultraceuticals US, LLC | ||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Zinc Oxide 12% 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.Directions Apply generously 15 minutes before sun exposure and Reapply at least every 2 hours. Children under 6 months of age: ask a doctor. 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 your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Caprylyl Methicone, Carnosine, Dimethicone, Isododecane, Lauryl PEG-10 Tris(Trimethylsiloxy) Silylethyl Dimethicone, Lauryl PEG-8 Dimethicone, Methylpropanediol, Niacinamide, Octyldodecyl Neopentanoate, PEG-10, Phenylpropanol, Polymethylsilsesquioxane, Propanediol, Silica, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Triceteareth-4 Phosphate, Tridecyl Salicylate, Water
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.RVR90 Firm Zinc Oxide Ultra UV Protective Mineral Defence SPF 50 Zinc Oxide ALKYL (C12-15) BENZOATE OCTYLDODECYL NEOPENTANOATE CAPRYLYL GLYCOL CAPRYLYL TRISILOXANE CARNOSINE ISODODECANE SODIUM HYDROXIDE LEVOMENOL SODIUM CHLORIDE PROPANEDIOL TETRASODIUM GLUTAMATE DIACETATE DIMETHICONE NIACINAMIDE ZINC OXIDE ZINC OXIDE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TRIDECYL SALICYLATE BUTYLOCTYL SALICYLATE METHYLPROPANEDIOL ALLANTOIN POLYETHYLENE GLYCOL 500 SILICON DIOXIDE TRICETEARETH-4 PHOSPHATE PHENYLPROPANOL WATER CAFFEINE Ultra Balancing Gel Cleanser DECYL GLUCOSIDE HYDROXYETHYL CELLULOSE, UNSPECIFIED GLYCOL DISTEARATE .ALPHA.-TOCOPHEROL ACETATE WATER CITRUS MAXIMA FRUIT RIND OIL SALICYLIC ACID CITRIC ACID MONOHYDRATE SODIUM BENZOATE BENZYL ALCOHOL FORMIC ACID POTASSIUM SORBATE LIMONENE, (+)- EDETATE DISODIUM PANTHENOL CUCUMBER GLYCERIN SODIUM LAUROYL LACTYLATE OATMEAL PROPANEDIOL MALTODEXTRIN SODIUM HYDROXIDE COCAMIDOPROPYL BETAINE SODIUM LAUROYL SARCOSINATE SODIUM CHLORIDE LAURETH-4 XANTHAN GUM SORBIC ACID ALOE VERA LEAF Ultra C Firming Serum ASCORBIC ACID CITRAL SODIUM LACTATE SODIUM METABISULFITE PALMITOYL HEXAPEPTIDE-12 LACTIC ACID LIMONENE, (+)- LAVENDER OIL YLANG-YLANG OIL CHAMAEMELUM NOBILE FLOWER OIL EDETATE DISODIUM DEXTRAN 1 PALMITOYL TETRAPEPTIDE-7 LINALOOL, (+/-)- GERANIOL .BETA.-CITRONELLOL, (R)- DIMETHYL ISOSORBIDE ANOGEISSUS LEIOCARPUS BARK SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CAPROOYL TETRAPEPTIDE-3 ALCOHOL SODIUM PHOSPHATE POLYSORBATE 20 TOCOPHEROL PALMITOYL TRIPEPTIDE-1 WATER PROPANEDIOL GLYCERIN SODIUM HYDROXIDE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYSORBATE 60 CAPRYLHYDROXAMIC ACID MENYANTHES TRIFOLIATA LEAF POLYETHYLENE GLYCOL 400 CAPRYLYL GLYCOL SODIUM PYRROLIDONE CARBOXYLATE BUTYLENE GLYCOL HYDROXYETHYL CELLULOSE, UNSPECIFIED SODIUM SULFITE MANDARIN OIL Ultra Hydrating Lotion DECYL OLEATE SODIUM LACTATE LINOLENIC ACID SOYBEAN OIL TERT-BUTYL ALCOHOL SODIUM HYDROXIDE LACTIC ACID OLIVE OIL DECYL ESTERS SQUALENE DIMETHICONE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER GLYCERYL MONOSTEARATE MALTODEXTRIN SODIUM PYRROLIDONE CARBOXYLATE UREA CETOSTEARYL ALCOHOL CETEARETH-12 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CHOLESTEROL TOCOPHEROL PHENYLPROPANOL CAPRYLYL GLYCOL HYALURONATE SODIUM ALOE VERA LEAF CETYL PALMITATE XANTHAN GUM BENZOIC ACID CETEARYL ISONONANOATE CITRIC ACID MONOHYDRATE GLYCERIN LECITHIN, SOYBEAN CERAMIDE NP METHYLPROPANEDIOL DICAPRYLYL CARBONATE WATER POLYOXYL 20 CETOSTEARYL ETHER LINOLEIC 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.Transform your skin in 90 Days Firm Delay the visible effects of time and boost the appearance of skin's firmness and resilience Facial Cleanser 6.76 fl. oz. Facial Serum 1.01 fl. oz. Facial Moisturizer 2.54 fl. oz. Sunscreen 3.38 fl. oz. Cosmetic Bag RVR 90 firm
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
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 Do not use on: damaged or broken skin When using this product keep out of eyes. Rinse with water to remove For external use only
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