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Pelle wellness spf 50 face and body broad spectrum mineral sunscreen - Medication Information

Product NDC Code 83625-101
Drug Name

Pelle wellness spf 50 face and body broad spectrum mineral sunscreen

Type Brand
Active Ingredients
Titanium dioxide 3 g/100ml
Zinc oxide 7 g/100ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Pelle Wellness LLC
Packages
Package NDC Code Description
83625-101-32 1000 ml in 1 bottle (83625-101-32)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS ZINC OXIDE 7.0% TITANIUM DIOXIDE 3.0%

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 generously and evenly 15 minutes before sun exposure Reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Use a water-resistant sunscreen if swimming. Children after 6 months: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Propanediol, Sodium PCA, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetyl Alcohol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric Acid, Sodium Citrate, Glyceryl Caprylate, Caprylyl Methicone, Alumina, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Cyclotetrasiloxane, Allantoin, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Glyceryl Undecylenate, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Panthenol, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Euterpe Oleracea Fruit Extract, Sodium Hyaluronate, Phenoxyethanol

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 Decreases the risk of skin cancer and early signs of 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.
PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE DIMETHICONE CAPRYLYL TRISILOXANE CYCLOMETHICONE 4 MATRICARIA CHAMOMILLA FLOWERING TOP TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE ETHYLHEXYL PALMITATE SODIUM PYRROLIDONE CARBOXYLATE GLYCERYL CAPRYLATE ALUMINUM OXIDE HYALURONATE SODIUM PHENOXYETHANOL WATER GLYCERIN CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE PROPANEDIOL GLYCERYL MONOSTEARATE PEG-100 STEARATE POLYSORBATE 60 CETYL ALCOHOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) CITRIC ACID MONOHYDRATE SODIUM CITRATE XANTHAN GUM TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE CHLORPHENESIN ALLANTOIN POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE GLYCERYL 1-UNDECYLENATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL EDETATE DISODIUM ANHYDROUS PANTHENOL CAMELLIA OLEIFERA LEAF CUCUMIS SATIVUS WHOLE EUTERPE OLERACEA WHOLE

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.
LBL

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.

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 626-877-8505

Storage and handling

Information about safe storage and handling of the drug product.
Protect this product from excessive heat and direct sun.

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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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 doctor if rash occurs.

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