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Product NDC Code | 68062-9000 | ||||
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Drug Name | Md glam spf 50 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Spa de Soleil | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Octinoxate 7.5% Zinc oxide 9.5%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: aqua, cocos nucifera (coconut) oil, carthamus tinctoris (safflower) seed oil, heptyl undecylenate, caprylic/capric triglyceride, cetyl alcohol, glycerin
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.Directions Directions Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.
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.MD Glam SPF 50 octinoxate HEPTYL UNDECYLENATE ZINC OXIDE ZINC OXIDE SAFFLOWER SEED CAPRYLIC/CAPRIC ACID WATER COCONUT OIL OCTINOXATE OCTINOXATE
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.Principal Display Panel MD GLAM SPF50 FINAL BOX 2 printOUT.jpg
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 the reach of children.
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 Warnings For external use only Do not use on damaged or broken skin When using this product keep out of the eye area rinse with water to remove stop use and ask a doctor if rash or irritation develops for external use onlyl keep out of reach of children Jar is glass and may shatter if dropped
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