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Product NDC Code | 75936-157 | ||||||
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Drug Name | Glow stick broad spectrum spf 50 |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | STICK | ||||||
Application Number | M020 | ||||||
Labeler Name | Supergoop, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients / Purpose Avobenzone 3%...... Sunscreen Octocrylene 10%... Sunscreen Octisalate 5%.......... 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 Apply generously and evenly 15 minutes before sun exposure Reapply: After 40 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 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-sleeved shirts, pants, hats and sunglasses Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Caprylic/Capric Triglyceride, Octyldodecanol, Isododecane, Isohexadecane, Dicaprylyl Carbonate, C12-15 Alkyl Benzoate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanoyl Glutamide, Diethylhexyl Syringylidenemalonate, Helianthus Annuus (sunflower) Seed Oil, Pentaclethra Macroloba Seed Oil, Maurita Flexuosa Fruit Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Callophyllum Inophyllum seed Oil, Calendula Officinalis Extract, Tocopherol
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for 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
Spl product data elements
Usually a list of ingredients in a drug product.Glow Stick Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE TOCOPHEROL SUNFLOWER OIL ISOHEXADECANE TAMANU OIL ISODODECANE ALKYL (C12-15) BENZOATE DIBUTYL LAUROYL GLUTAMIDE OCTYLDODECANOL MEADOWFOAM SEED OIL FATTY ACIDS CALENDULA OFFICINALIS FLOWER MEDIUM-CHAIN TRIGLYCERIDES DICAPRYLYL CARBONATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) DIBUTYL ETHYLHEXANOYL GLUTAMIDE DIETHYLHEXYL SYRINGYLIDENEMALONATE PENTACLETHRA MACROLOBA SEED OIL MAURITIA FLEXUOSA FRUIT OIL OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE
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.Supergoop! Glow Stick Sunscreen SPF 50 Broad Spectrum Sunscreen SPF 50 1.23 oz./ 35 g stick back label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration Section
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,
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.
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