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Product NDC Code | 65692-0509 | ||||||||
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Drug Name | Juice box spf 15 broad spectrum lip balm |
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Type | Generic | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | STICK | ||||||||
Application Number | M020 | ||||||||
Labeler Name | Raining Rose, Inc | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%
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.Applly liberally 15 minutes before sun exposure
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Aloe Extract, Canola Oil, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic
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.Helps prevent sunburn
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.Juice Box SPF 15 Broad Spectrum Lip Balm Juice Box SPF 15 Broad Spectrum Lip Balm SUNFLOWER OIL MONO/DIGLYCERIDES SOYBEAN OIL SUNFLOWER OIL TOCOPHEROL ROSEMARY WHITE WAX OLIVE OIL CANNABIS SATIVA SEED OIL ALOE VERA LEAF OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OCTINOXATE OCTINOXATE CANOLA OIL
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 C10816 SPF 15 BS JUICE BOX
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 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. If swallowed, get medical help or contact a Poison Control Center right away.
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 well 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.Warnings For external use only
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