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Cover-expert sunscreen broad spectrum spf 15 no.12 warm copper - Medication Information

Product NDC Code 69879-112
Drug Name

Cover-expert sunscreen broad spectrum spf 15 no.12 warm copper

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 51 mg/ml
Zinc oxide 28 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Luxe Art Beaute SAS
Packages
Package NDC Code Description
69879-112-35 35 ml in 1 tube (69879-112-35)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium dioxide 5.1% Zinc oxide 2.8% Purpose Sunscreen

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, cyclopentasiloxane, talc, glycerin, cetyl peg/ppg-10/1 dimethicone, imperata (imperata cylindrica) root extract, sodium chloride, benzyl alcohol, triethoxycaprylylsilane, c12-13 alkyl lactate, alumina, sodium dehydroacetate, hydrogen dimethicone, dimethicone/vinyl dimethicone crosspolymer, fragrance, squalane, disteardimonium hectorite, peg-8, aluminum hydroxide, potassium sorbate, dehydroacetic acid, propylene carbonate, carbomer, phenoxyethanol, sodium citrate, citric acid, biotin may contain: ​titanium dioxide, iron oxides

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 Help to 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. Directions Apply liberally 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 invcreases your 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

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.
Cover-Expert Sunscreen Broad Spectrum SPF 15 No.12 Warm Copper TITANIUM DIOXIDE, ZINC OXIDE WATER CYCLOMETHICONE 5 TALC GLYCERIN IMPERATA CYLINDRICA ROOT SODIUM CHLORIDE BENZYL ALCOHOL TRIETHOXYCAPRYLYLSILANE ALUMINUM OXIDE SODIUM DEHYDROACETATE DIMETHICONE SQUALANE DISTEARDIMONIUM HECTORITE POLYETHYLENE GLYCOL 400 ALUMINUM HYDROXIDE POTASSIUM SORBATE DEHYDROACETIC ACID PROPYLENE CARBONATE PHENOXYETHANOL SODIUM CITRATE CITRIC ACID MONOHYDRATE BIOTIN 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.
Product Label l1 l2

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

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 swallowed, get medical help or contact 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

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 swallowed, get medical help or contact 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