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Product NDC Code | 63505-771 | ||||
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Drug Name | Solaire peau parfaite mineral screen spf 30 |
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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 | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Yves Rocher North America Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 19 % 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.undefined • Apply generously and evenly 15 minutes before sun exposure. • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 am - 2 pm • wear long-sleeved shirts, pants, hats, and sunglasses. • For use on children less than 6 months of age, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Coco-Caprylate, Caprylic/ Capric Triglyceride, Cetearyl Isononanoate, Ethylhexyl Palmitate, Glycerin, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Isopropyl Myristate, Magnesium Sulfate, Tocopherol, Polyglyceryl-3 Polyricinoleate, Decylene Glycol, Camellia Sinensis Leaf Extract, Lecithin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunfl ower) Seed Oil, 1,2-Hexanediol, Xanthan Gum, Hydrogenated Castor Oil, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera/Cire de candelilla, Sodium Chloride, Isostearic Acid, Silica, Polyhydroxystearic Acid, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Citric Acid.
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.Use 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.Solaire peau Parfaite Mineral Screen SPF 30 ZINC OXIDE WATER COCO-CAPRYLATE MEDIUM-CHAIN TRIGLYCERIDES CETEARYL ISONONANOATE ETHYLHEXYL PALMITATE GLYCERIN ISOPROPYL PALMITATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE ISOPROPYL MYRISTATE MAGNESIUM SULFATE, UNSPECIFIED FORM TOCOPHEROL DECYLENE GLYCOL GREEN TEA LEAF ALOE VERA LEAF SUNFLOWER OIL 1,2-HEXANEDIOL XANTHAN GUM HYDROGENATED CASTOR OIL CANDELILLA WAX SODIUM CHLORIDE ISOSTEARIC ACID SILICON DIOXIDE SODIUM BENZOATE POTASSIUM SORBATE PHENOXYETHANOL CITRIC ACID MONOHYDRATE 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.Package Labeling: Label01
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
Other Information • Protect the product in this container from excessive heat and direct sun. • Store at 15-30°C (59-86°F).
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.undefined 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 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? CAN: 1-800-361-2746 / USA 1-800-321-3434.
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. Discontinue 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 undefined on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Discontinue 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