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| Product NDC Code | 76293-372 | ||||
|---|---|---|---|---|---|
| Drug Name | Sage and zinc facial hydrating spf15 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Emeis Cosmetics Pty Ltd | ||||
| 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 ingredient Zinc Oxide 19.5%
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 liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply: At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures . Spending time in the sun increases 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-sleeve shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Glycerin, Coco-Caprylate/Caprate, Octyldodecanol, Acrylates Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Macadamia Integrifolia Seed Oil, Squalane, Polyglyceryl-3 Polyricinoleate, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Tocopheryl Acetate, Saccharide Isomerate, Oenothera Biennis (Evening Primrose) Oil, Silica, Isostearic Acid, Lavandula Angustifolia (Lavender) Oil, Glycine Soja (Soybean) Oil, Salvia Officinalis (Sage) Oil, 1,2-Hexanediol, Caprylyl Glycol, Sodium Gluconate, Fusanus Spicatus Wood Oil, Tocopherol, Polysorbate 60, Sorbitan Isostearate, Ethylhexylglycerin, Calcium Chloride, Glycine Soja (Soybean) Seed Extract, Citric Acid, Sodium Citrate, Potassium Sorbate, Xylose, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Linalool, Farnesol, Limonene, Geraniol.
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.Sage and Zinc Facial Hydrating SPF15 Zinc Oxide ZINC OXIDE ZINC OXIDE CALCIUM CHLORIDE SOYBEAN SODIUM CITRATE POTASSIUM SORBATE XYLOSE CARROT SILICON DIOXIDE TOCOPHEROL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) MACADAMIA OIL POLYGLYCERYL-3 PENTARICINOLEATE EVENING PRIMROSE OIL SAGE OIL SORBITAN ISOSTEARATE COCO-CAPRYLATE/CAPRATE CAPRYLYL GLYCOL SODIUM GLUCONATE SANTALUM SPICATUM OIL POLYSORBATE 60 GERANIOL LUVISET 360 BETA CAROTENE LINALOOL, (+/-)- FARNESOL LIMONENE, (+)- SACCHARIDE ISOMERATE PEG-30 DIPOLYHYDROXYSTEARATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE SOYBEAN OIL 1,2-HEXANEDIOL LAVENDER OIL ETHYLHEXYLGLYCERIN SQUALANE OCTYLDODECYL XYLOSIDE ISOSTEARIC ACID CITRIC ACID MONOHYDRATE OCTYLDODECANOL WATER GLYCERIN
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 Packaging Aesop. SPF 15 Sage & Zinc Facial Hydrating Lotion Zinc Oxide Tocopheryl Acetate Sage Leaf Broad-spectrum SPF15 Sunscreen Daily-use moisturiser providing mineral-based, SPF15 sunscreen protection. Suitable for most skin types, including sensitive. Massage evenly over the face and neck after cleansing and reapply during the day to maintain protection aesop.com Net wt. 57 g/2.0Oz. sage and zinc
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
Company Information Manufactured in Australia. Aesop, 25 Smith Street, Fitzroy 3065, Australia. +61 3 9412 8900 [email protected] Distributed by Aesop USA Inc, 48 West 25th St. New York, NY, 10010
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sun. You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222
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 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. 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