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| Product NDC Code | 76296-060 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Caudalie daily mineral sunscreen broad spectrum spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Caudalie USA, Inc. | ||||||||
| Packages |
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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 generously and evenly 15 minutes before sun exposure. • Reapply at least every 2 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, regulalry 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 singlasses. •Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua/Water/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Erythritol, Lauryl Laurate, Propanediol, Carthamus Tinctorius Oleosomes, Bentonite, Niacinamide, Palmitoyl Grapevine Shoot Extract, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Helianthus Annuus (Sunflower) Seed Oil,Sucrose Stearate, Coco-Glucoside, Bisabolol, Citric Acid, Caramel, Polyhydroxystearic Acid, Pongamia Pinnata Seed Extract, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Tocopherol, Microcrystallnine Cellulose, Beta-Sitosterol, Gluconolactone, Squalene, Xanthan Gum, Aloe Barbadensis Leaf Juice Powder, Sodium Benzoate.
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.Active ingredient Purpose Zinc Oxide 21.1% ...... Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 Zinc Oxide PROPANEDIOL CARTHAMUS TINCTORIUS SEED OLEOSOMES CAPRYLHYDROXAMIC ACID GLYCERIN SODIUM GLUCONATE NIACINAMIDE BUTYLOCTYL SALICYLATE LEVOMENOL .BETA.-SITOSTEROL GLUCONOLACTONE SODIUM BENZOATE CITRIC ACID MONOHYDRATE CARAMEL PONGAMIA PINNATA SEED XANTHAN GUM BOROSILICATE GLASS TOCOPHEROL MICROCRYSTALLINE CELLULOSE WATER MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF SUNFLOWER OIL ERYTHRITOL POLYHYDROXYSTEARIC ACID (2300 MW) LAURYL LAURATE BENTONITE ETHYL FERULATE COCO GLUCOSIDE CETOSTEARYL ALCOHOL CAPRYLYL GLYCOL SUCROSE STEARATE SQUALENE ZINC OXIDE ZINC OXIDE
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.30 mL Pack 30 mL Outer Label_Page_1 30 mL Outer Label_Page_2 30 mL Inner Label
50 mL Pack 50 mL Outer Label 50 mL Inner Label
Co-pack Copack 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.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.When using this product • keep out of eyes. Rinse with water to remove.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • Protect the product in this contaner from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-866-826-1615
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.
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.
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