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| Product NDC Code | 66097-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Tinted sunscreen cream spf 30 4-deep amber |
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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 | C.F.E.B. - Sisley | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium dioxide 12.93% Zinc oxide 10.89%
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. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months of age: ask a doctor. Spending time in the sun increases your risk of skin cancern and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, c9- 12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, dimethicone, hydrogenated lecithin, disodium edta, glyceryl caprylate, ethylhexyglycerin, synthetic fluorphlogopite, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.
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.Tinted Sunscreen Cream SPF 30 4-Deep Amber TITANIUM DIOXIDE, ZINC OXIDE WATER CAPRYLYL TRISILOXANE GLYCERIN POLYGLYCERYL-3 DIISOSTEARATE SILICON DIOXIDE SHEA BUTTER POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE CAMELLIA OIL SODIUM CHLORIDE .ALPHA.-TOCOPHEROL ACETATE MANGO THYMUS MASTICHINA FLOWERING TOP OIL SAGE OIL ALUMINUM OXIDE DIMETHICONE HYDROGENATED SOYBEAN LECITHIN EDETATE DISODIUM ANHYDROUS GLYCERYL MONOCAPRYLATE ETHYLHEXYLGLYCERIN TRIETHOXYCAPRYLYLSILANE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BENZOIC ACID SODIUM BENZOATE POTASSIUM SORBATE FERRIC OXIDE RED LINALOOL, (+/-)- LIMONENE, (+)- TITANIUM DIOXIDE TITANIUM DIOXIDE 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 Box Tube Drug Facts
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.Other information Protect the product in the container from excessive heat or direct sun.
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.
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