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Product NDC Code | 84245-272 | ||||
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Drug Name | Lipbrella 100% mineral tinted lip oil spf 20 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OIL | ||||
Application Number | M020 | ||||
Labeler Name | Mama Sol LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients..Purpose Zinc Oxide 7.5%.....Sunscreen (non-nano)
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 directly onto lips, alone or as a topper • Reapply as needed • Use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Drug Facts (cont'd) Inactive Ingredients Polybutene, Octyldodecanol, Bis-Diglyceryl Polyacyladipate-2, Helianthus Annuus (Sunflower) Seed Oil, Caprylic Capric Triglyceride, Dimethyl Isosorbide, Sesamum Indicum (Sesame) Seed Extract, Tocopherol (Vitamin E), Candelilla Wax, Ascorbyl Palmitate (Vitamin C), Oenothera Biennis (Evening Primrose) Oil*, Borago Officinalis Seed Oil*, Tocopheryl Acetate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Stevia Rebaudiana Leaf/Stem Extract*, Ricinus Communis (Castor) Seed Oil, May Contain +/- Iron Oxides / Yellow 5, Red 7 Lake, Red 27 Lake
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 • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun
Purpose
Information about the drug product’s indications for use.Drug Facts Active Ingredients..Purpose Zinc Oxide 7.5%.....Sunscreen (non-nano)
Spl product data elements
Usually a list of ingredients in a drug product.LIPBRELLA 100% Mineral Tinted Lip Oil SPF 20 Zinc Oxide ZINC OXIDE ZINC OXIDE TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES FD&C YELLOW NO. 5 SESAMUM INDICUM WHOLE CANDELILLA WAX EVENING PRIMROSE OIL ASCORBYL PALMITATE DIMETHYL ISOSORBIDE CASTOR OIL D&C RED NO. 27 BORAGE SEED OIL STEVIA REBAUDIUNA LEAF D&C RED NO. 7 OCTYLDODECANOL SUNFLOWER OIL POLYHYDROXYSTEARIC ACID (2300 MW) COCONUT OIL POLYBUTENE (1400 MW) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALPHA-TOCOPHEROL ACETATE
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.LIPBRELLA The love child of balm and gloss, our innovative SPF 20 lip oil treatment protects lips with a hint of shine + color. This unique formula, packed with nourishing oils, helps plump for fuller-looking lips, smooths the appearance of dry or chapped skin, and softens the look of vertical lines around the mouth for a comfy, hydrated pout.
LipBrella Packaging LipBrella Packaging
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.Warnings • 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.Drug Facts (cont'd) Sun Protection Measures Spending time in the sun increases your chance 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 • for children under 6 months, ask a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun.
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. Stop use and ask a doctor if rash occurs. If swallowed, get medical help or contact a Poison Control center right away.
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