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| Product NDC Code | 53634-129 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf 30 lip balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Malin and Goetz Inc | ||||
| 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 Ingredient Purpose Titanium Dioxide 3.32% Sunscreen
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 and evenly 15 minutes before sun exposure Children under 6 months of age: Ask a doctor Sun Protection Measures Spending time in the sun increases your risk 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 am- 2pm Wear long-sleeved shirts, pants, hats & sunglasses Reapply after 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.
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.Stop use and ask a doctor If rash occurs
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Spl product data elements
Usually a list of ingredients in a drug product.spf 30 Lip Balm Titanium Dioxide CINNAMYL ALCOHOL EUGENOL ALUMINUM HYDROXIDE HYDROGENATED POLYDECENE TYPE I LIMONENE, (+)- METHYL HEPTINE CARBONATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) COUMARIN TOCOPHEROL URSOLIC ACID CINNAMALDEHYDE TITANIUM DIOXIDE TITANIUM DIOXIDE STEARIC ACID HYDROGENATED POLYBUTENE (1300 MW) ETHYLHEXYL PALMITATE
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.(Malin+Goetz) spf 30 lip balm. Broad Spectrum Mineral Sunscreen Water Resistant 40 minutes 0.3fl. oz./10ml lip balm carton lip balm tube
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 the product in this container 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
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