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| Product NDC Code | 68828-003 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Spa niacinamide and vitamin e hand cream broad spectrum spf 15 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Jafra Cosmetics International Inc | ||||||||
| 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 Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%
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.Direction • Apply liberally 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: Ask a doctor • Sun Protection Measures. 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 your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Polyester-8, Butyrospermum Parkii (Shea) Butter, Dimethicone, Styrene/Acrylates Copolymer, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Saccharide Isomerate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Isohexadecane, Niacinamide, Hydroxyethyl Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Arginine, Chlorphenesin, Arachidyl Glucoside, Disodium EDTA, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Sorbitan Isostearate, Polysorbate 60, Olea Europaea (Olive) Fruit Oil, Fragrance
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.Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 avobenzone, homosalate, octisalate, octocrylene WATER GLYCERIN SHEA BUTTER DIMETHICONE ETHYLHEXYLGLYCERIN BENZYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE ARACHIDYL ALCOHOL SACCHARIDE ISOMERATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) DOCOSANOL ISOHEXADECANE NIACINAMIDE HYDROXYETHYL UREA CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) .ALPHA.-TOCOPHEROL ACETATE ARGININE CHLORPHENESIN ARACHIDYL GLUCOSIDE EDETATE DISODIUM PANTHENOL AVOCADO OIL SORBITAN ISOSTEARATE POLYSORBATE 60 OLIVE OIL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Product label image description
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.Other information 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.Warning 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 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