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| Product NDC Code | 70157-009 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hydrating body sunscreen uva and uvb broad spectrum spf50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Baxter Laboratories Pty. Ltd. | ||||||||
| 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 Purpose Homosalate 10% .............Sunscreen Octocrylene 8% ...............Sunscreen Octisalate 5% ..................Sunscreen Avobenzone 3% ..............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 generously and evenly 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 10a.m.-2p.m. wear long sleeve shirts, pants, hats and sunglasses Children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Beeswax, Isopropryl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinensis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric Acid
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.Hydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50 Homosalate, Octocrylene, Octisalate, Avobenzone CYCLOMETHICONE 6 HYALURONATE SODIUM MALTODEXTRIN KAKADU PLUM CITRIC ACID MONOHYDRATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HOMOSALATE HOMOSALATE WATER ISOPROPYL PALMITATE HYDROXYACETOPHENONE BENZYL ALCOHOL TROLAMINE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE YELLOW WAX CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 POLYOXYL 20 CETOSTEARYL ETHER PHENOXYETHANOL SODIUM STEAROYL GLUTAMATE JOJOBA OIL RASPBERRY SEED OIL .ALPHA.-TOCOPHEROL ACETATE GLYCERIN ALOE VERA LEAF OCTISALATE OCTISALATE
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.frank body SPF 50+ Hydrating Body Sunscreen UVA + UVB Broad Spectrum SPF50+ With hyaluronic acid Fast absorbing Water resistant (80 minutes) 4.73fl oz - 140ml SPF 50 hydrating label
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 our of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other informaiton Protect the product in this container from excessive heat and direct sun Questions or comments? Contact us at frankbody.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 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. 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