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Product NDC Code | 82723-001 | ||||||||
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Drug Name | Face spf 47 setting |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SPRAY | ||||||||
Application Number | M020 | ||||||||
Labeler Name | Aopline Health Industry Technology (Guangzhou) Co., Ltd. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%
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 to face 15 minutes before sun exposure. Reapply every 2 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate
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, decrease the risk of skin cancer and early skin aging caused by 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.Face SPF 47 Setting Face SPF 47 Setting Spray EUCALYPTUS GLOBULUS LEAF SUNFLOWER OIL ALCOHOL CYCLOMETHICONE 6 MELALEUCA ALTERNIFOLIA LEAF ETHYLHEXYL PALMITATE ALPHA-TOCOPHEROL HYALURONIC ACID PEPPERMINT CYCLOMETHICONE 5 NIACINAMIDE ASCORBIC ACID OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE
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.Package Label 82723-001-01 50mL
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 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. 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 Children under 6 months ask a physician.
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 Stop use and ask a physician 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.For External Use Only. Do not use on damaged or broken skin. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.
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. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.
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