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| Product NDC Code | 70604-050 | ||||
|---|---|---|---|---|---|
| Drug Name | Daily beauty regimen with trihex technology |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Alastin Skincare, Inc. | ||||
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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 Purpose Titanium Dioxide 8.9% Sunscreen Zinc Oxide 3.4% Sunscreen
| Titanium Dioxide 8.9% | Sunscreen |
| Zinc Oxide 3.4% | 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 Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months of age: Ask a doctor. 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 time in the sun, especially from 10am - 2pm Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Stearic Acid, Thermus Thermophillus Ferment, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Camellia Sinensis Leaf Extract, Hydroxymethoxyphenyl Decanone, Dunaliella Salina Extract, Asteriscus Graveolens Flower/Fruit/Leaf/Stem Extract, Ergothioneine, Ectoin, Squalane, Glycerin, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Sodium Citrate, Potassium Sorbate, Dipropylene Glycol, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
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.Uses Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Active Ingredients Purpose Titanium Dioxide 8.9% Sunscreen Zinc Oxide 3.4% Sunscreen
| Titanium Dioxide 8.9% | Sunscreen |
| Zinc Oxide 3.4% | Sunscreen |
Spl product data elements
Usually a list of ingredients in a drug product.Daily Beauty Regimen with TriHex Technology titanium dioxide and zinc oxide HydraTint Pro Mineral Broad Spectrum Sunscreen SPF titanium dioxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER CYCLOMETHICONE 5 DIMETHICONE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) BUTYLENE GLYCOL ALUMINUM HYDROXIDE STEARIC ACID THERMUS THERMOPHILUS LYSATE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE SODIUM CHLORIDE GREEN TEA LEAF 1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE DUNALIELLA SALINA ERGOTHIONEINE ECTOINE SQUALANE GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE/PEG-10/15 CROSSPOLYMER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ETHYLHEXYLGLYCERIN TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE PEG/PPG-18/18 DIMETHICONE TRIETHOXYCAPRYLYLSILANE SODIUM CITRATE, UNSPECIFIED FORM POTASSIUM SORBATE DIPROPYLENE GLYCOL PHENOXYETHANOL FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE Gentle Cleanser WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE OAT ODETIGLUCAN PANTHENOL GLYCERIN LEVOMENOL PHENOXYETHANOL SODIUM CHLORIDE PANTOLACTONE 1,2-HEXANEDIOL CAPRYLYL GLYCOL SODIUM BENZOATE POTASSIUM SORBATE SODIUM HYDROXIDE ANHYDROUS CITRIC ACID ETHYLHEXYLGLYCERIN EDETATE DISODIUM ANHYDROUS MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE LAVENDER OIL ORANGE OIL, COLD PRESSED STANNIC OXIDE TOCOPHEROL TITANIUM DIOXIDE Restorative Skin Complex WATER GLYCERIN PROPANEDIOL NIACINAMIDE ISOPROPYL PALMITATE POLYACRYLATE-13 BUTYLENE GLYCOL PALMITOYL HEXAPEPTIDE-12 PALMITOYL TRIPEPTIDE-1 PALMITOYL TRIPEPTIDE-5 TRIFLATE PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE TRIFLUOROACETATE PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID TRIFLUOROACETATE ACETYL HEXAPEPTIDE-38 ASCORBYL PALMITATE SWERTIA CHIRAYITA WHOLE PEA PROTEIN ORNITHINE CERAMIDE NP ERGOTHIONEINE DUNALIELLA SALINA LECITHIN, SOYBEAN TREMELLA FUCIFORMIS FRUITING BODY OLIVE OIL SOYBEAN OIL SHEA BUTTER BETAINE SQUALANE CAPRYLYL TRISILOXANE EDETATE DISODIUM ANHYDROUS POLYSORBATE 20 TOCOPHEROL CAPRYLYL GLYCOL CAPRYLHYDROXAMIC ACID POLYISOBUTYLENE (1000 MW) POTASSIUM SORBATE LEVULINIC ACID SODIUM HYDROXIDE SUNFLOWER OIL P-ANISIC ACID SORBITAN ISOSTEARATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL Ultra Nourishing Moisturizer WATER MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL TRISILOXANE GLYCERIN CETOSTEARYL ALCOHOL DIMETHICONE GLYCERYL MONOOLEATE CITRATE GLYCERYL MONOSTEARATE PALMITOYL TRIPEPTIDE-1 PALMITOYL HEXAPEPTIDE-12 SUNFLOWER OIL OAT TREMELLA FUCIFORMIS FRUITING BODY RICE BRAN ROSEMARY LECITHIN, SOYBEAN LEVOMENOL .ALPHA.-TOCOPHEROL GLYCERYL MONOOLEATE CAPRYLYL GLYCOL SOY STEROL LINOLEIC ACID EDETATE DISODIUM ANHYDROUS BETAINE POLYACRYLATE-13 POLYISOBUTYLENE (1000 MW) POLYSORBATE 20 CAPRYLHYDROXAMIC ACID ETHYLHEXYLGLYCERIN PHENOXYETHANOL POTASSIUM SORBATE BENZYL ALCOHOL SODIUM BENZOATE SORBITAN ISOSTEARATE
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 - Kit Carton ALASTIN ® SKINCARE DAILY BEAUTY REGIMEN with TriHex Technology ® Designed to help restore and renew skin to maintain a healthy, youthful appearance. PRINCIPAL DISPLAY PANEL - Kit 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
Distributed by Alastin Skincare ® Inc., a Galderma Company Carlsbad, CA 92010
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. Store at room temperature 15° - 30°C (59° - 86°F).
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