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| Product NDC Code | 73088-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral lip balm spf-15 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIPSTICK | ||||
| Application Number | M020 | ||||
| Labeler Name | TUBBY TODD | ||||
| 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 Zinc Oxide 10.5%
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.Drug Facts
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor*, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Butter*, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil*, Calophyllum Inophyllum (Tamanu) Seed Oil* *Certified organic ingredient(s)
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 protect against sunburn and chapped lips.
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.Mineral Lip Balm SPF-15 ZINC OXIDE SUNFLOWER OIL YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES COCONUT OIL POLYHYDROXYSTEARIC ACID (2300 MW) SHEA BUTTER RUBUS IDAEUS SEED TOCOPHEROL COCOA BUTTER JOJOBA OIL TAMANU OIL ZINC OXIDE ZINC CATION
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.01b LBL_Lip Balm_SPF15_Key Lime 01b LBL_Mineral Lip Balm SPF-15_Pina Colada
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally and as needed.
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 amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately.
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.
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
• Stop use and ask a doctor if rash occurs
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 Stop use and ask a doctor if rash occurs Keep out of reach of children. If amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately. • Stop use and ask a doctor if rash occurs • Stop use and ask a doctor if rash occurs
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