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Product NDC Code | 10028-022 | ||||
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Drug Name | Starter set dry/normal skin |
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Type | Brand | ||||
Route | TOPICAL | ||||
Dosage Form | KIT | ||||
Application Number | part352 | ||||
Labeler Name | Ultraceuticals Pty Ltd | ||||
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
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.Starter Set Dry/Normal Skin Zinc Oxide Ultra UV Protective Mineral Defence SPF 50 Zinc Oxide ISODODECANE PROPANEDIOL TRICETEARETH-4 PHOSPHATE SILICON DIOXIDE SODIUM CHLORIDE TETRASODIUM GLUTAMATE DIACETATE DIMETHICONE METHYLPROPANEDIOL WATER ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE CAPRYLYL TRISILOXANE CARNOSINE LEVOMENOL CAFFEINE CAPRYLYL GLYCOL NIACINAMIDE OCTYLDODECYL NEOPENTANOATE POLYETHYLENE GLYCOL 500 PHENYLPROPANOL SODIUM HYDROXIDE TRIDECYL SALICYLATE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ZINC OXIDE ZINC OXIDE ALLANTOIN Ultra Hydrating Milk Cleanser OLIVE OIL DECYL ESTERS TOCOPHEROL CUCUMBER MEDIUM-CHAIN TRIGLYCERIDES PANTHENOL SODIUM PYRROLIDONE CARBOXYLATE PYRROLIDONE CARBOXYLIC ACID GLYCERIN METHYLPROPANEDIOL PROPANEDIOL WATER GRAPE SEED OIL CAPRYLYL GLYCOL SORBITAN OLIVATE POLYOXYL 40 HYDROGENATED CASTOR OIL EDETATE DISODIUM ANHYDROUS CITRUS MAXIMA FRUIT RIND OIL POTASSIUM SORBATE CETEARYL OLIVATE PPG-26-BUTETH-26 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PHENYLPROPANOL SODIUM HYDROXIDE SOYBEAN OIL SQUALENE LACTIC ACID LIMONENE, (+)- Ultra B2 Hydrating Serum TREHALOSE SALICYLIC ACID SORBIC ACID POTASSIUM SORBATE NIACINAMIDE HYALURONATE SODIUM PANTHENOL SODIUM PYRROLIDONE CARBOXYLATE PYRROLIDONE CARBOXYLIC ACID WATER PROPANEDIOL UREA GLYCERIN CUCUMBER BENZYL ALCOHOL Ultra Moisturiser Cream PHENYLPROPANOL COCONUT OIL VANILLIN POLYSORBATE 60 LINOLEIC ACID SODIUM PYRROLIDONE CARBOXYLATE PYRROLIDONE CARBOXYLIC ACID SORBITAN ISOSTEARATE CAPRYLYL GLYCOL EDETATE DISODIUM EDETIC ACID XANTHAN GUM DIMETHICONE UREA CERAMIDE NP LINOLENIC ACID CHOLESTEROL CETETH-20 STEARETH-20 SODIUM HYDROXIDE LACTIC ACID ALKYL (C12-15) BENZOATE METHYLPROPANEDIOL GLYCERYL MONOBEHENATE CETYL ALCOHOL TOCOPHEROL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) PEG-75 STEARATE WATER SHEA BUTTER GLYCERIN CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE SODIUM LACTATE HYALURONATE SODIUM
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 Dry/Normal Skin Ultra Hydrating Milk Cleanser 200ML Ultra B2 Hydrating Serum 30ML Ultra Moisturiser Cream 75ML Ultra UV Protective Mineral Defence SPF 50+ 100ML Normal Dry Set
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