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Clarins super restorative day illuminating lifting replenishing broad spectrum - spf 20 - sunscreen - Medication Information

Product NDC Code 58668-0961
Drug Name

Clarins super restorative day illuminating lifting replenishing broad spectrum - spf 20 - sunscreen

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 100 mg/ml
Octocrylene 27 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Laboratoires Clarins S.A.
Packages
Package NDC Code Description
58668-0961-1 1 jar in 1 carton (58668-0961-1) / 50 ml in 1 jar
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 2.7%

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 apply to all skin exposed to the sun children under 6 month: Ask a doctor Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: AQUA/WATER/EAU - GLYCERIN - BUTYLOCTYL SALICYLATE - C12-15 ALKYL BENZOATE - ALCOHOL - DIMETHICONE - CETEARYL ALCOHOL - OLUS OIL/VEGETABLE OIL/HUILE VEGETALE - PENTYLENE GLYCOL - BUTYROSPERMUM PARKII (SHEA) BUTTER - POTASSIUM CETYL PHOSPHATE - TROMETHAMINE - CETEARYL GLUCOSIDE - PARFUM/FRAGRANCE - ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER - ASCORBYL GLUCOSIDE - SUCROSE PALMITATE - TOCOPHERYL ACETATE - HYDROGENATED VEGETABLE OIL - ETHYLHEXYLGLYCERIN - XANTHAN GUM - BUTYLENE GLYCOL - GLYCERYL LINOLEATE - SODIUM HYALURONATE - DISODIUM EDTA - CANDELILLA CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA - TOCOPHEROL - MICA - CI 77120/BARIUM SULFATE - CI 77891/TITANIUM DIOXIDE - HARUNGANA MADAGASCARIENSIS EXTRACT - CITRIC ACID - POTASSIUM SORBATE - PROPANEDIOL - OLEA EUROPAEA (OLIVE) FRUIT EXTRACT - PECTIN - THERMUS THERMOPHILUS FERMENT - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE - PHENOXYETHANOL - LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT - CAMELLIA SINENSIS LEAF EXTRACT - RHODIOLA ROSEA ROOT EXTRACT - CI 14700/RED 4 - SODIUM LAURYL SULFATE - ACETYL TETRAPEPTIDE-2 - DEXTRAN. [S2628A]

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 decreases the risk of skin cancer and early skin aging caused by the sun (see Directions),

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.
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE WATER GLYCERIN BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE ALCOHOL DIMETHICONE CETOSTEARYL ALCOHOL PENTYLENE GLYCOL SHEA BUTTER POTASSIUM CETYL PHOSPHATE TROMETHAMINE CETEARYL GLUCOSIDE ASCORBYL GLUCOSIDE SUCROSE PALMITATE .ALPHA.-TOCOPHEROL ACETATE ETHYLHEXYLGLYCERIN XANTHAN GUM BUTYLENE GLYCOL GLYCERYL MONOLINOLEATE HYALURONATE SODIUM EDETATE DISODIUM CANDELILLA WAX TOCOPHEROL MICA BARIUM SULFATE TITANIUM DIOXIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE PROPANEDIOL BLACK OLIVE PECTIN THERMUS THERMOPHILUS LYSATE SUNFLOWER OIL PHENOXYETHANOL LAPSANA COMMUNIS FLOWERING TOP GREEN TEA LEAF SEDUM ROSEUM ROOT FD&C RED NO. 4 SODIUM LAURYL SULFATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE

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.
CLARINS PARIS Haute Exigence Jour SPF 20 Super Restorative Day Illuminating lifting replenishing cream All skin types BROAD SPECTRUM - SPF 20 - Sunscreen e 50 mL 1.7 Oz. Net Wt. CLARINS Super Restorative Day Illuminating lifting replenishing cream BROAD SPECTRUM - SPF 20 - Sunscreen 50ml (58668-0961-1) Insert Label Jar Label Outer Label

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.
CLARINS Super Restorative Day Illuminating lifting replenishing cream BROAD SPECTRUM - SPF 20 - Sunscreen Other information: protect this product from excessive heat and direct sun "CLARINS: effective, serious treatments, ensuring maximum results with the highest quality ingredients." Jacques Courtin Clarins Super Restorative Day SPF 20 All skin types Protective skin care which meets the specific needs of skin weakened by hormonal changes linked to ageing. For skin that looks incredibly radiant and beautiful. • Replenishes the skin at all levels, visibly lifts, helps fight against skin slackening A powerful plant extract of harungana* helps to replenish the skin and fight against skin slackening**. The look of wrinkles is reduced and the skin appears toned and lifted. • Helps minimize the appearance of age spots, instantly illuminates, provides long-lasting nourishment A vitamin C derivative and sun filters help encourage a more even complexion and beauty-enhancing pigments revive complexion radiance. Hyaluronic acid and shea butter provide moisturization and comfort. Anti-pollution and sun protection. Dermatologist tested. Noncomedogenic. *Patent application (FR). **In vitro tests. CLARINS PARIS - 92200 Neuilly - 95300 Pontoise - France Made in France - Brevets (FR, WO) et marques déposés Patent applications (FR, WO) www.clarins.com CLARINS-PARIS 18 M ref. 10961 9

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.

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 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

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.

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