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| Product NDC Code | 73572-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Personalized day moisturizer with spf 50 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Proven Skincare | ||||
| 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 12% 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 • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor 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. Sun Protection Measures
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients • Water, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Jojoba Esters, Glycerin, Methylpropanediol, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Caprylyl Glycol, Allantoin, Fragrance, Pyrus Malus (Apple) Fruit Extract, Lysolecithin, Sclerotium Gum, Lecithin, Phenylpropanol, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Tocopherol, Sodium Hydroxide
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 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.Personalized Day Moisturizer with SPF 50 ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES ISOAMYL LAURATE SQUALANE BUTYLOCTYL SALICYLATE GLYCERIN METHYLPROPANEDIOL CETYL ALCOHOL GLYCERYL MONOSTEARATE SILICON DIOXIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE PEG-75 STEARATE CAPRYLYL GLYCOL ALLANTOIN APPLE BETASIZOFIRAN PHENYLPROPANOL PULLULAN XANTHAN GUM CETETH-20 STEARETH-20 ALOE VERA LEAF LEVOMENOL TETRASODIUM GLUTAMATE DIACETATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL TOCOPHEROL SODIUM HYDROXIDE 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: Label
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? go to www.provenskincare.com Made in USA from local and imported materials Manufactured for PROVEN, Miami, FL, 33131
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 using 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 on damaged or broken skin Stop using and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. 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