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Pure haven essentials - Medication Information

Product NDC Code 71355-819
Drug Name

Pure haven essentials

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 60 mg/ml
Zinc oxide 60 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Pure Haven LLC
Packages
Package NDC Code Description
71355-819-03 90 ml in 1 tube (71355-819-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Titanium Dioxide (6.00%) Zinc Oxide (6.00%) 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: Apply liberally 15-minutes before sun exposure. Reapply: - At least every tow-hours. - Immediately after swimming, sweating or towel drying. Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For childre under 6-months, consult with a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Other Ingredients Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

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.
Pure Haven Essentials TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF WATER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETEARYL OLIVATE PUMPKIN SEED OIL ETHYLHEXYL PALMITATE GLYCERIN GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE ALMOND SESAME OIL SORBITAN OLIVATE COCOA XANTHAN GUM 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: 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 Inf ormation: Protect this product from excessive heat and direct sunlight.

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 product is swallowed, get medical attention or contact poison control center immediately.

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 consult physician if irritation or rash develops.

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 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 consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.

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