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Product NDC Code | 0316-0269 | ||||
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Drug Name | Panoxyl oil am control moisturizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Crown Laboratories | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 17%
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 • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only • 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 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • Reapply to dry skin : • At least every 2 hours • Use a water resistant suscreen if swimming for sweating • Keep out of reach of children • Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenethyl Alcohol, Polyglyceryl-4 Laurate/Succinate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysorbate 60, Purified Water, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Isostearate, Sorbitan Monostearate, Tapioca Starch, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E),Triethoxycaprylylsilane, Xanthan Gum
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 and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risks 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.PanOxyl Oil AM Control Moisturizer Zinc Oxide SORBITAN MONOSTEARATE STARCH, TAPIOCA LEVOMENOL BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE CAFFEINE CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN GLYCERIN 1,2-HEXANEDIOL HYDROXYACETOPHENONE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) PHENYLETHYL ALCOHOL POLYGLYCERYL-4 LAURATE/SUCCINATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYMETHYLSILSESQUIOXANE (11 MICRONS) POLYSORBATE 60 WATER .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE XANTHAN GUM ZINC OXIDE ZINC OXIDE SODIUM HYDROXIDE SORBITAN ISOSTEARATE TETRASODIUM GLUTAMATE DIACETATE HYALURONATE SODIUM
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.PanOxyl Oil Control Moisturizer 1.7oz Tube DERMATOLOGIST RECOMMENDED PanOxyl AM OIL CONTROL MOISTURIZER Broad Spectrum SPF 30 Mineral Sunscreen Lightweight Daily Moisturizer Absorbs Excess Oil UVA/UVB Protection Won't Clog Pores Net wt. 1.7oz (48g) P12073.00 PanOxyl Oil Control Moisturizer Tube
PanOxyl Oil Control Moisturizer 1.7oz Carton New Sheer Formula DERMATOLOGIST RECOMMENDED PanOxyl AM OIL CONTROL MOISTURIZER Broad Spectrum SPF 30 Mineral Sunscreen Lightweight Daily Moisturizer Absorbs Excess Oil UVA/UVB Protection Won't Clog Pores Net wt. 1.7oz (48g) P12074.00 PanOxyl Oil Control Moisturizer Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Update title of section. Formatted Uses section Formatted Directions section
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 • Children under 6 months: ask a doctor
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 May stain some fabrics
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 1-800-877-8869 or visit www.panoxyl.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 • When using this product • Keep out of eyes. Rinse with water to remove • Stop use and ask doctor if rash or irritation occurs • Do not use: • On damaged or broken skin • If allergic to any ingredient • If swallowed, get medical help or contact a Poison Control Center
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