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| Product NDC Code | 51514-0332 | ||||||||||
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| Drug Name | Josie maran argan daily moisturizer spf47 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Autumn Harp, 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 Zinc Oxide 6.4%** Titanium Dioxide 5.1%**
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.Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua (Water)**, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride**, Aloe Barbadensis Leaf Juice*, Polyglyceryl-6 Polyricinoleate**, Cyclopentasiloxane, Polysilicone-11, Argania Spinosa (Argan) Kernel Oil**, Glycerin**, Cera Alba (Beeswax)*, Coco-Caprylate/Caprate, Phenoxyethanol, Polyhydroxystearic Acid, Methicone, Alumina, Tocopheryl Acetate, Sodium Chloride**, Triethoxycaprylylsilane, Polyglyceryl-10 Laurate, Parfum (Fragrance)**, Bisabolol, Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil*, Laureth-12, Ethylhexylglycerin, Camellia Sinensis (Green Tea) Leaf Extract*, Citric Acid**, Potassium Sorbate**, Sodium Benzoate**. *ORGANIC **NATURAL
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Josie Maran Argan Daily Moisturizer SPF47 Zinc Oxide, Titanium Dioxide WATER CYCLOMETHICONE 5 ETHYLHEXYL PALMITATE MEDIUM-CHAIN TRIGLYCERIDES POLYGLYCERYL-6 DIOLEATE POLYSILICONE-15 ARGAN OIL GLYCERIN COCO-CAPRYLATE/CAPRATE YELLOW WAX PHENOXYETHANOL POLYHYDROXYSTEARIC ACID (2300 MW) METHICONE (20 CST) ALUMINUM OXIDE .ALPHA.-TOCOPHEROL ACETATE SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE POLYGLYCERYL-10 LAURATE APRICOT LEVOMENOL JOJOBA OIL DIMETHICONE ALOE VERA LEAF LAURETH-12 LINALOOL, (+/-)- ETHYLHEXYLGLYCERIN LIMONENE, (+/-)- GREEN TEA LEAF .ALPHA.-AMYLCINNAMALDEHYDE POTASSIUM SORBATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Principle Display Panel \ Image Components 15 ml carton 15 ml label 120 ml carton 60 ml carton 5 ml carton 5 ml label 120 ml label 60 ml label
Instructions for use
Information about safe handling and use of the drug product.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: Ask a doctor
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: · Protect this product from excessive heat and direct sun.
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.Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm. • Wear long-sleeve shirts, pants, hats, and sunglasses
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.Drug Facts
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.For external use only Do not use on damaged or broken skin When using this product, keep out of eyes
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