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| Product NDC Code | 83625-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Pelle wellness spf 30 face and body broad spectrum mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Pelle Wellness LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 6.0% TITANIUM DIOXIDE 2.5%
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 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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cyclohexasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Sucrose Cocoate, Citric Acid, Glyceryl Isostearate, Polyhydroxystearic Acid, Sodium Citrate, Sodium PCA, Caprylyl Methicone, Alumina, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Chlorphenesin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Allantoin, Xanthan Gum, Glyceryl Undecylenate, Glycerin, Magnesium Ascorbyl Phosphate, Panthenol, Phytic Acid, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Phenoxyethanol, Sodium Hyaluronate
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 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE FYTIC ACID DIMETHICONE CAPRYLYL TRISILOXANE CYCLOMETHICONE 6 MATRICARIA CHAMOMILLA FLOWERING TOP TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE SODIUM PYRROLIDONE CARBOXYLATE GLYCERYL CAPRYLATE ALUMINUM OXIDE GLYCERYL MONOSTEARATE HYALURONATE SODIUM PHENOXYETHANOL WATER GLYCERIN CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE PROPANEDIOL PEG-100 STEARATE 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) SUCROSE COCOATE GLYCERYL 1-UNDECYLENATE PANTHENOL CAMELLIA OLEIFERA LEAF CUCUMIS SATIVUS WHOLE MAGNESIUM ASCORBYL PHOSPHATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL ISOSTEARATE
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