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| Product NDC Code | 68479-291 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Porescreen spf40 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Dermalogica, LLC. | ||||||||
| Packages |
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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 Zinc Oxide (10%)
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 Shake before each use. Apply evenly and liberally to face, 15 minutes prior to sun exposure. Can be worn alone or underneath make-up. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To help 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 of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Isododecane, Lauryl PEG-8 Dimethicone, Propanediol, Niacinamide, Methylpropanediol, Titanium Dioxide (CI 77891), Silica Silylate, Lactic Acid, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosa Damascena Extract, Chlorella Vulgaris Extract, Sea Salt (Maris Sal), Olive Oil Decyl Esters, Squalene, Tocopherol, Caprylyl Glycol, Lecithin, Allantoin, Propylene Glycol Stearate, Glycerin, Bisabolol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, PEG-10, Silica, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Magnesium Stearate, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Hydroxide, Sodium Chloride, Bentonite, Cellulose Acetate, Phenylpropanol, Hydrated Silica, Acrylates/Ammonium Methacrylate Copolymer, Iron Oxides (CI 77491, CI 77492, CI 77499), Linalool.
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. If used as directed with other sun protection measures (see Directions , helps decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.PORESCREEN SPF40 Zinc Oxide Zinc Oxide Zinc Oxide Water ALKYL (C12-15) BENZOATE Octyldodecyl Neopentanoate Butyloctyl Salicylate MEDIUM-CHAIN TRIGLYCERIDES Isododecane Propanediol Methylpropanediol Niacinamide Titanium Dioxide SILICON DIOXIDE Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate Sodium Chloride Bentonite Caprylyl Glycol FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW SUNFLOWER OIL LECITHIN, SOYBEAN Allantoin Cellulose Acetate Olive Oil Decyl Esters Phenylpropanol PROPYLENE GLYCOL MONOSTEARATE Magnesium Stearate CITRIC ACID MONOHYDRATE Glycerin Hydrated Silica POLYETHYLENE OXIDE 200000 Tetrasodium Glutamate Diacetate LACTIC ACID, DL- LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP LEVOMENOL Squalene MATRICARIA CHAMOMILLA WHOLE ROSA X ALBA FLOWER OIL CHLORELLA VULGARIS Sea Salt Sodium Hydroxide Tocopherol LINALOOL, (+/-)-
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 - 30 mL Tube Carton dermalogica porescreen SPF 40 high protection UVA UVB broad spectrum with niacinamide blurring + hint of tint mineral sunscreen Sun Care 1.0 US FL OZ / 30 mL ℮ Principal Display Panel - 30 mL Tube 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
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 swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-800-831-5150 in the US.
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 this product from excessive heat and direct sun.
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 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