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Marlowe spf 50 - Medication Information

Product NDC Code 82215-0001
Drug Name

Marlowe spf 50

Type Brand
Active Ingredients
Avobenzone 29.94 mg/ml
Homosalate 99.8 mg/ml
Octisalate 49.9 mg/ml
Octocrylene 49.9 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Marlowe Holdings, LLC
Packages
Package NDC Code Description
82215-0001-3 100 ml in 1 tube (82215-0001-3)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocryle 5%

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 80 minutes of swimming and 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 the 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. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cetyl Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-100 Stearate, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Propylene Glycol, Silica, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

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.
Marlowe SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene ALPHA-TOCOPHEROL ACETATE WATER PEG-100 STEARATE GLYCERYL MONOSTEARATE PHENYL TRIMETHICONE CARBOMER INTERPOLYMER TYPE A (55000 CPS) ALOE VERA LEAF SHEA BUTTER CETYL ALCOHOL COCOA BUTTER GLYCYRRHIZA GLABRA PROPYLENE GLYCOL SILICON DIOXIDE STEARYL ALCOHOL SODIUM HYDROXIDE PHENOXYETHANOL CETYL PHOSPHATE HIGH DENSITY POLYETHYLENE ETHYLHEXYLGLYCERIN TETRASODIUM GLUTAMATE DIACETATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE off white

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.
Marlowe No. 128 Daily Face Lotion with SPF 50 Principal Display Label

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Ohter Information Protect this product 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 or Comments Call 1-(855)-923-5073, Mon-Fri

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 wih 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 wih 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