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| Product NDC Code | 81104-110 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Glow body mist spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | NAKED SUNDAYS 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.AVOBENZONE 3% SUNSCREEN HOMOSALATE 10% SUNSCREEN OCTISALATE 5 % SUNSCREEN OCTOCRYLENR 8 % SUNSCREEN
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 Generously spray to exposed areas holding bottle 10-15 cm away from skin. Ensure even application by spraying at least 7 times per section of body until product is visible, Rub in lightly. Use a water- resistant sunscreen if swimming or sweating. reapply at least every 2 hours. Children under 6 months of age : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alcohol, Citrullius Lanatus Seed oil, Kakadu Plum, Tocopheryl Acetate, Fragrance
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.USE Helps prevent Sunburn If used as directed with other sun Protection measure ( see directions), decrease the risk of skin cancer and early skin ageing caused by the sun
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.GLOW BODY MIST SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KAKADU PLUM ALCOHOL WATERMELON SEED OIL OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE .ALPHA.-TOCOPHEROL ACETATE
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.Label 1
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 Product is 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 & direct sun
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.warning For External use Only Do not use on damaged or broken skin
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