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Product NDC Code | 69026-487 | ||||
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Drug Name | Dew skin tinted moisturizer broad spectrum no5 spf 20 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Beauty Counter, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxdie 14.0% Purpose 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 as needed daily Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor. Sun Protection Measures Spending time in the sun increases the 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 10 a.m. - 2 p.m. wear long- sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Coco-Caprylate, Trimethylsiloxysilicate, Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Octyldodecyl Oleate, Ethylhexyl Palmitate, Isopropyl Myristate, Dimethicone, Magnesium Sulfate, Beeswax, Gluconolactone, Glycerin, Isoeicosane, Propanediol, Hydrogenated Castor Oil, Sodium Chloride, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Tetrahexyldecyl Ascorbate, Sodium Benzoate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Octyldodecyl Stearoyl Stearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Paeonia Suffruticosa Root Extract, Calcium Gluconate, Rosa Damascena Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Salvia Sclarea (Clary) Oil, Vanilla Planifolia Fruit, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgaurea (Goldenrod) Extract ,Tocopherol ,Sodium Hyaluronate , May Contain (+/-): Titanium Dioxide (CI 77891) Yellow Iron Oxide (CI 77492) Iron Oxides (CI 77491) Iron Oxide (CI 77499) Mica (CI 77019)
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), decreases the risk of skin cancer and early skin aging caused by 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.Dew Skin Tinted Moisturizer Broad Spectrum No5 SPF 20 Zinc Oxide WATER MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ISOPROPYL PALMITATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE OCTYLDODECYL OLEATE ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE DIMETHICONE MAGNESIUM SULFATE, UNSPECIFIED YELLOW WAX GLUCONOLACTONE GLYCERIN ISOEICOSANE PROPANEDIOL HYDROGENATED CASTOR OIL SODIUM CHLORIDE BLACK CURRANT OCTYLDODECANOL TETRAHEXYLDECYL ASCORBATE SODIUM BENZOATE ALMOND OIL ISOSTEARIC ACID LECITHIN, SOYBEAN POLYGLYCERYL-3 RICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) OCTYLDODECYL STEAROYL STEARATE BERGAMOT OIL ALCOHOL ORANGE OIL PAEONIA SUFFRUTICOSA ROOT CALCIUM GLUCONATE ROSA DAMASCENA FLOWER OIL ORANGE PEEL CLARY SAGE OIL VANILLA PLANIFOLIA WHOLE ROSEMARY OIL SOLIDAGO VIRGAUREA WHOLE TOCOPHEROL HYALURONATE SODIUM TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW MICA ZINC OXIDE ZINC CATION
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.DStintedNo5
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 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.
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.
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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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. 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.
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