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Juice box spf 15 broad spectrum lip balm - Medication Information

Product NDC Code 65692-0509
Drug Name

Juice box spf 15 broad spectrum lip balm

Type Generic
Active Ingredients
Avobenzone .09 g/4.25g
Octinoxate .28 g/4.25g
Octisalate .21 g/4.25g
Octocrylene .06 g/4.25g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name Raining Rose, Inc
Packages
Package NDC Code Description
65692-0509-1 4.25 g in 1 tube (65692-0509-1)
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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