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| Product NDC Code | 42485-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Broad spectrum spf 30 up the anti |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Biopelle, 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 Ingredients Zinc Oxide 6.0% Titanium Dioxide 3.2%
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 to face and under throat after cleansing reapply: after excessive perspiration 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 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.
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 protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Broad Spectrum SPF 30 Up The Anti TITANIUM DIOXIDE, ZINC OXIDE WATER ETHYLHEXYL PALMITATE CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE DIMETHICONE POLYSORBATE 80 PEG-100 STEARATE GLYCERYL MONOSTEARATE PROPYLENE GLYCOL CETYL ALCOHOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) GLYCERIN CYCLOMETHICONE 6 CAPRYLYL TRISILOXANE ALUMINUM OXIDE ISOHEXADECANE BORON NITRIDE SODIUM LEVULINATE PHENOXYETHANOL POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM ANISATE TRIETHOXYCAPRYLYLSILANE PANTHENOL IODOPROPYNYL BUTYLCARBAMATE ALOE VERA LEAF DMDM HYDANTOIN ALLANTOIN EDETATE SODIUM METHYLPARABEN ETHYLPARABEN BUTYLPARABEN BUTYLENE GLYCOL PROPYLPARABEN ISOBUTYLPARABEN MATRICARIA CHAMOMILLA WHOLE CAMELLIA SINENSIS WHOLE FERRIC OXIDE RED TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
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.Broad Spectrum SPF 30 Up The Anti 75ml (42485-005-01) UPTHEANTI UPTHEANTIBase
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Broad Spectrum SPF 30 Up The Anti
PRESCRIBEDsolutions is Distributed By Biopelle, Inc. A Ferndale Pharma Group Company, Ferndale, MI 48220 Made In USA
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 product is swallowed, get medical help or contact a Poison Control Center right away.
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? Call toll free 1-866-424-6735 (weekdays)
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.
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