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| Product NDC Code | 61477-224 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Aloe up medicated lip balm spf 30 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LIPSTICK | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Aloe Care International, LLC | ||||||||||
| 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.ACTIVE INGREDIENTS AVOBENZONE (2%) HOMOSALATE (7.5%) OCTISALATE (5%) OCTOCRYLENE (2.5%) OXYBENZONE (6%)
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 liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aloe Vera Leaf Extract, Camphor Powder, Canola Oil, Castor Oil, Cetyl Alcohol, Menthol, Ozokerite Wax, Petrolatum, Titanium Dioxide, Tocopherol, Triethoxycaprylylsilane.
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.USES 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.ALOE UP MEDICATED LIP BALM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE ALOE VERA LEAF CAMPHOR (SYNTHETIC) CANOLA OIL CETYL ALCOHOL MENTHOL CERESIN PETROLATUM TITANIUM DIOXIDE TOCOPHEROL TRIETHOXYCAPRYLYLSILANE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE
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.LBL_Aloe Up Sport Medicated Lip Balm SPF-30
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 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 this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? Toll Free 800-950-2563 www.aloeup.com
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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs 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