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Teint miracle octinoxate sunscreen broad spectrum spf 15 - Medication Information

Product NDC Code 70581-004
Drug Name

Teint miracle octinoxate sunscreen broad spectrum spf 15

Type Brand
Active Ingredients
Octinoxate 30 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name BPS 60
Packages
Package NDC Code Description
70581-004-01 1 bottle in 1 box (70581-004-01) / 110 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Octinoxate 3% 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.
Directions For sunscreen use: •shake well • apply liberally 15 minutes before sun exposure • reaply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • children under 6 months of age: Ask a doctor Sun Protection Measures.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, tin oxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, silica silylate, alumina, aluminum hydroxide, magnesium silicate, magnesium sulfate, disodium stearoyl glutamate, synthetic fluorphlogopite, ethylhexyl hydroxystearate, tocopheryl acetate, fragrance, linalool, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, hexyl cinnamal; may contain: red28 lake, red 7, mica, titanium dioxide, blue 1 lake, bismuth oxychloride, 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 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.
Teint Miracle Octinoxate Sunscreen Broad Spectrum SPF 15 OCTINOXATE MAGNESIUM SULFATE, UNSPECIFIED DISODIUM STEAROYL GLUTAMATE ETHYLHEXYL HYDROXYSTEARATE .ALPHA.-TOCOPHEROL ACETATE LINALOOL, (+/-)- HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE BUTYLPHENYL METHYLPROPIONAL .ALPHA.-HEXYLCINNAMALDEHYDE WATER CYCLOMETHICONE 5 ALCOHOL PHENYL TRIMETHICONE GLYCERIN PEG-10 DIMETHICONE (600 CST) BIS-PEG/PPG-14/14 DIMETHICONE STANNIC OXIDE ROSA GALLICA FLOWER TALC DIMETHICONE METHICONE (20 CST) ALUMINUM OXIDE ALUMINUM HYDROXIDE MAGNESIUM SILICATE OCTINOXATE OCTINOXATE

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: Label2

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 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? 1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

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 near fire, flame or heat. Flammable untill dry. 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 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