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Product NDC Code | 52667-006 | ||||
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Drug Name | 100% pure yerba mate mist spf 30 |
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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 | AEROSOL, SPRAY | ||||
Application Number | part352 | ||||
Labeler Name | Purity Cosmetics | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 12%
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 Do not spray directly onto face. Spray into hands and rub onto your face. To ensure adequate sun protection, avoid spreading too thinly when applying. Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours 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 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. Children under 6 months: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water
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 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.100% Pure Yerba Mate MIst SPF 30 Zinc Oxide COCO GLUCOSIDE HEPTYL UNDECYLENATE ILEX PARAGUARIENSIS LEAF WATER GLYCERIN BUTYLOCTYL SALICYLATE SAFFLOWER OIL CETOSTEARYL ALCOHOL METHYL DIHYDROABIETATE ZINC OXIDE ZINC CATION BENTONITE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL JOJOBA OIL, RANDOMIZED
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.100% Pure Yerba Mate Mist SPF 30 Representative Image
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? call 1.844.787.3100 or visit www.100PercentPure.com
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 eye. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sunlight.
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 Contents under pressure. Do not puncture or incinerate. For external use only Do not spray directly on face . Do not use on damaged or broken skin. S top use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.
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