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| Product NDC Code | 65966-018 | ||||
|---|---|---|---|---|---|
| Drug Name | The sof fluid long wear foundation broad spectrum spf 20 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | MAX HUBER RESEARCH LAB INC | ||||
| 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 Octinoxate 7.5% Titanium dioxide 1.9%
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 For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 10 a.m. – 2 p.m. wear long-sleeved 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 DECLUSTERED WATER (-)\AQUA\EAU DE-STRUCTUREE (-) • DECLUSTERED WATER (+)\AQUA\EAU DE-STRUCTUREE (+) • CYCLOPENTASILOXANE • ISODODECANE • DIMETHICONE • PHENYL TRIMETHICONE • BUTYLENE GLYCOL • POLYMETHYL METHACRYLATE • POLYSILICONE-11 • COCO-CAPRYLATE/CAPRATE • PEG/PPG-18/18 DIMETHICONE • OCTYLDODECYL NEOPENTANOATE • SILICA • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYGLYCERYL-4 ISOSTEARATE • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • MOLASSES EXTRACT\SACCHARUM OFFICINARUM\EXTRAIT DE MELASSE • CHLORELLA VULGARIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • CORALLINA OFFICINALIS EXTRACT • SACCHAROMYCES LYSATE EXTRACT • SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • LAMINARIA SACCHARINA EXTRACT • CODIUM TOMENTOSUM EXTRACT • SUCROSE • GLYCERIN • CHOLESTEROL • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • GLYCINE SOJA (SOYBEAN) PROTEIN • ACETYL GLUCOSAMINE • CAFFEINE • SORBITOL • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • TOURMALINE • ACETYL HEXAPEPTIDE-8 • SODIUM HYALURONATE • HEXYL LAURATE • CETYL PEG/PPG-10/1 DIMETHICONE • DISTEARDIMONIUM HECTORITE • C12-16 ALCOHOLS • MAGNESIUM ALUMINUM SILICATE • TREHALOSE • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • DIMETHICONE SILYLATE • PROPYLENE GLYCOL DIETHYLHEXANOATE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • TRIETHYL CITRATE • TETRAHEXYLDECYL ASCORBATE • STEARIC ACID • PALMITIC ACID • HYDROGENATED LECITHIN • METHICONE • PROPYLENE GLYCOL DICAPRATE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM CHLORIDE • ALUMINUM HYDROXIDE • HEXYLENE GLYCOL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • ALCOHOL DENAT. • DISODIUM EDTA • BHT • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN42899>
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 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.THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE and TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 ISODODECANE DIMETHICONE PHENYL TRIMETHICONE BUTYLENE GLYCOL POLY(METHYL METHACRYLATE; 450000 MW) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) COCOYL CAPRYLOCAPRATE PEG/PPG-18/18 DIMETHICONE OCTYLDODECYL NEOPENTANOATE SILICON DIOXIDE NORI SESAME OIL ALFALFA SEED HELIANTHUS ANNUUS SEEDCAKE ALMOND EUCALYPTUS OIL SODIUM GLUCONATE COPPER GLUCONATE CALCIUM GLUCONATE MAGNESIUM GLUCONATE ZINC SUCCINATE .ALPHA.-TOCOPHEROL SUCCINATE, D- NIACIN SESAME SEED POLYGLYCERYL-4 ISOSTEARATE LIME PEEL CHONDRUS CRISPUS CARRAGEENAN CUCUMBER HORDEUM VULGARE WHOLE MOLASSES CHLORELLA VULGARIS PLOCAMIUM CARTILAGINEUM CORALLINA OFFICINALIS SACCHAROMYCES LYSATE MILK THISTLE WHEY SACCHARINA LATISSIMA CODIUM TOMENTOSUM SUCROSE GLYCERIN CHOLESTEROL LAMINARIA DIGITATA SOY PROTEIN N-ACETYLGLUCOSAMINE CAFFEINE SORBITOL ACETYL HEXAPEPTIDE-8 HYALURONATE SODIUM HEXYL LAURATE DISTEARDIMONIUM HECTORITE C12-16 ALCOHOLS MAGNESIUM ALUMINUM SILICATE TREHALOSE YEAST, UNSPECIFIED PROPYLENE GLYCOL DIETHYLHEXANOATE CAPRYLYL GLYCOL TRIETHYL CITRATE TETRAHEXYLDECYL ASCORBATE STEARIC ACID PALMITIC ACID HYDROGENATED SOYBEAN LECITHIN METHICONE (20 CST) PROPYLENE GLYCOL DICAPRATE SODIUM CHLORIDE ALUMINUM HYDROXIDE HEXYLENE GLYCOL TRIETHOXYCAPRYLYLSILANE ALCOHOL EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE PHENOXYETHANOL MICA FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE
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 Bottle Carton SKINCOLOR DE LA MER™ LA MER the soft fluid long wear foundation broad spectrum SPF 20 net wt. 1 oz./30 ml e PRINCIPAL DISPLAY PANEL - 30 ml Bottle 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 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
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