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| Product NDC Code | 54473-224 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Affinia facial moisturizer |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Melaleuca, 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 1.8%, Homosalate 6%, Octisalate 3%, Octocrylene 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 For sunscreen use: • apply smoothly on cleansed skin • apply liberally 15 mintues before sun exposure • use a water-resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: 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 time in the sun, especially from 10a.m.-2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, 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.Affinia Facial Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE .ALPHA.-TOCOPHEROL ACETATE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CALCIUM PANTOTHENATE CETYL ALCOHOL CITRIC ACID MONOHYDRATE COCOA BUTTER DIMETHICONE GLYCERIN GLYCERYL MONOSTEARATE GLYCERYL STEARATE SE MALTODEXTRIN MANGIFERA INDICA SEED BUTTER METHYLISOTHIAZOLINONE NIACINAMIDE PEG-100 STEARATE PHENOXYETHANOL PHENOXYETHYL CAPRYLATE POTASSIUM SORBATE PYRIDOXINE HYDROCHLORIDE SHEANUT OIL SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE SODIUM STEAROYL GLUTAMATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE WATER XANTHAN GUM HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE
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.Image of box
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 When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is rash occurs. Keep out of reach of children . If swallowed, get medical help or contact Poison Control Center right away.
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 Poison Control Center right away.
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 ask a doctor is rash occurs. Keep out of reach of children . If swallowed, get medical help or contact Poison Control Center right away.
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. Stop use and ask a doctor is rash occurs. Keep out of reach of children . If swallowed, get medical help or contact Poison Control Center right away.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.Other information • for normal-to-dry skin • dermatologist and allergy tested • may stain some fabrics • protect this product from excessive heat and direct sun • do not store at temperatures below 32°F (0°C) or above 120°F (49°C) Inactive ingredients Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Water/Eau), Butyrospermum Parkii (Shea Butter), Calcium Pantothenate, Cetyl Alcohol, Citric Acid, Dimethicone, Glycerin, Glyceryl Stearate, Maltodextrin, Mangifera Indica (Mango) Seed Butter, Methylisothiazolinone, Niacinamide, Parfum, PEG-100 Stearate, Phenoxyethanol, Phenoxyethyl Caprylate, Polyacrylate-15 (and) Polyacrylate-17, Potassium Sorbate, Pyridoxine HCL, Silica, Sodium Ascorbyl Phosphate, Sodium Starch Octenylsuccinate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Xanthan Gum
Storage and handling
Information about safe storage and handling of the drug product.• protect this product from excessive heat and direct sun • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
General precautions
Information about any special care to be exercised for safe and effective use of the drug.• may stain some fabrics • protect this product from excessive heat and direct sun • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
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 When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is rash occurs. Keep out of reach of children . If swallowed, get medical help or contact 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