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| Product NDC Code | 65966-019 | ||||
|---|---|---|---|---|---|
| Drug Name | La mer the luminous lifting cushion foundation broad spectrum spf 20 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | MAX HUBER RESEARCH LAB INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Titanium Dioxide 6.5%
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 WATER\AQUA\EAU • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • DIMETHICONE • METHYL TRIMETHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • GLYCERIN • BUTYLENE GLYCOL • PENTYLENE GLYCOL • PEG-10 DIMETHICONE • 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 • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CODIUM TOMENTOSUM EXTRACT • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • MAGNESIUM SULFATE • ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER • DIMETHICONE CROSSPOLYMER • DISTEARDIMONIUM HECTORITE • LAUROYL LYSINE • ETHYLHEXYLGLYCERIN • POLYHYDROXYSTEARIC ACID • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • CAPRYLYL GLYCOL • LECITHIN • ISOPROPYL MYRISTATE • ISOSTEARIC ACID • ETHYLHEXYL PALMITATE • STEARIC ACID • POLYGLYCERYL-3 POLYRICINOLEATE • ALUMINA • ALUMINUM HYDROXIDE • TOCOPHEROL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • POTASSIUM SORBATE • ALCOHOL DENAT. • DISODIUM EDTA • BHT • LINALOOL • CITRONELLOL • GERANIOL • LIMONENE • HYDROXYCITRONELLAL • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN44570>
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.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 Titanium Dioxide CAPRYLYL GLYCOL ISOPROPYL MYRISTATE ISOSTEARIC ACID ETHYLHEXYL PALMITATE STEARIC ACID ALUMINUM OXIDE ALUMINUM HYDROXIDE TOCOPHEROL TRIETHOXYCAPRYLYLSILANE POTASSIUM SORBATE ALCOHOL EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE LINALOOL, (+/-)- .BETA.-CITRONELLOL, (R)- GERANIOL LIMONENE, (+)- HYDROXYCITRONELLAL YEAST, UNSPECIFIED PHENOXYETHANOL MICA FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE DIMETHICONE METHYL TRIMETHICONE DIPHENYLSILOXY PHENYL TRIMETHICONE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE GLYCERIN BUTYLENE GLYCOL PENTYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) SESAME OIL ALFALFA SEED HELIANTHUS ANNUUS SEEDCAKE EUCALYPTUS OIL SODIUM GLUCONATE COPPER GLUCONATE CALCIUM GLUCONATE MAGNESIUM GLUCONATE ZINC GLUCONATE .ALPHA.-TOCOPHEROL SUCCINATE, D- NIACIN LIME PEEL CODIUM TOMENTOSUM ERYNGIUM MARITIMUM WHOLE LAMINARIA DIGITATA ACETYL HEXAPEPTIDE-8 MAGNESIUM SULFATE, UNSPECIFIED FORM DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DISTEARDIMONIUM HECTORITE LAUROYL LYSINE ETHYLHEXYLGLYCERIN
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 - 12 g x 2 Container Carton SKINCOLOR DE LA MER™ LA MER the luminous lifting cushion foundation broad spectrum SPF 20 total poids net wt. 0.84 oz./24g e (12g x 2) PRINCIPAL DISPLAY PANEL - 12 g x 2 Container 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