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Product NDC Code | 10028-020 | ||||
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Drug Name | Starter set oily/normal skin |
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Type | Brand | ||||
Route | TOPICAL | ||||
Dosage Form | KIT | ||||
Application Number | part352 | ||||
Labeler Name | ULTRACEUTICALS PTY LIMITED | ||||
Packages |
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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 liberally 15 minutes before sun exposure and at least every 2 hours Children under 6 months 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 sunglassesof age: ask a doctor. 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 or irritation develops and lasts.
Purpose
Information about the drug product’s indications for use.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.Starter Set Oily/Normal Skin Zinc Oxide Ultra Protective Protective Mineral Defence SPF 50 Zinc oxide ALLANTOIN DIMETHICONE ISODODECANE CAPRYLYL TRISILOXANE CARNOSINE METHYLPROPANEDIOL OCTYLDODECYL NEOPENTANOATE CAFFEINE POLYMETHYLSILSESQUIOXANE (11 MICRONS) NIACINAMIDE PHENYLPROPANOL ALKYL (C12-15) BENZOATE PROPANEDIOL SILICON DIOXIDE SODIUM CHLORIDE SODIUM HYDROXIDE TRICETEARETH-4 PHOSPHATE TRIDECYL SALICYLATE WATER POLYETHYLENE GLYCOL 500 TETRASODIUM GLUTAMATE DIACETATE CAPRYLYL GLYCOL ZINC OXIDE ZINC OXIDE Ultra Balancing Gel Cleanser XANTHAN GUM CITRUS MAXIMA FRUIT RIND OIL CITRIC ACID MONOHYDRATE EDETATE DISODIUM EDETIC ACID GLYCERIN FORMIC ACID MALTODEXTRIN LAURETH-4 BENZYL ALCOHOL ALOE VERA LEAF SODIUM HYDROXIDE GLYCOL DISTEARATE EDETATE SODIUM EDETIC ACID POTASSIUM SORBATE OATMEAL PROPANEDIOL LIMONENE, (+)- COCAMIDOPROPYL BETAINE SODIUM LAUROYL SARCOSINATE DECYL GLUCOSIDE MAGNESIUM ALUMINUM SILICATE SODIUM LAUROYL LACTYLATE WATER SORBIC ACID PANTHENOL SALICYLIC ACID SODIUM BENZOATE SODIUM CHLORIDE .ALPHA.-TOCOPHEROL ACETATE CUCUMBER Ultra B2 Hydrating Serum NIACINAMIDE HYALURONATE SODIUM PROPANEDIOL WATER PANTHENOL BENZYL ALCOHOL UREA SODIUM PYRROLIDONE CARBOXYLATE PYRROLIDONE CARBOXYLIC ACID GLYCERIN CUCUMBER TREHALOSE SALICYLIC ACID POTASSIUM SORBATE SORBIC ACID Ultra Hydrating Lotion CHOLESTEROL DIMETHICONE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) CETEARYL ISONONANOATE TOCOPHEROL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CETYL PALMITATE GLYCERYL MONOSTEARATE METHYLPROPANEDIOL DICAPRYLYL CARBONATE DECYL OLEATE TERT-BUTYL ALCOHOL LACTIC ACID OLIVE OIL DECYL ESTERS SQUALENE HYALURONATE SODIUM UREA LINOLEIC ACID SODIUM PYRROLIDONE CARBOXYLATE PYRROLIDONE CARBOXYLIC ACID LINOLENIC ACID ALOE VERA LEAF CETOSTEARYL ALCOHOL WATER GLYCERIN BENZOIC ACID CITRIC ACID MONOHYDRATE XANTHAN GUM POLYOXYL 20 CETOSTEARYL ETHER SOYBEAN OIL CETEARETH-12 CAPRYLYL GLYCOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PHENYLPROPANOL SODIUM HYDROXIDE MALTODEXTRIN SODIUM LACTATE LECITHIN, SOYBEAN CERAMIDE NP
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.Starter Set Oil/ Normal Skin Begin your Journey with Ultraceuticals Starter Packs Ultra UV Protective Mineral Defence SPF 50+ 100ML Ultra Balancing Cleanser 200ML Ultra B2 Hydrating Serum 30ML Ultra Hydrating Lotion 75ML Oily Normal setr
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