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| Product NDC Code | 84754-052 | ||||||||
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| Drug Name | Jmsolution marine luminous pearl sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | GPNY CORP | ||||||||
| 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 Avobenzone 2.7 % Homosalate 9.8 % Octisalate 4.7 % Octocrylene 9.7 %
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 15 minutes before sun exposure. 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 ■ children under 6 months of age: Ask a doctor ■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Butyloctyl Salicylate, Niacinamide, Polysorbate 80, Dipropylene Glycol, Benzyl Glycol, Sea Water, Glycerin, Glyceryl Stearate SE, Polymethylsilsesquioxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Poly C10-30 Alkyl Acrylate, Butylene Glycol, Arginine, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Ethyl Hexanediol, Caulerpa Lentillifera Extract, Tocopheryl Acetate, 1,2-Hexanediol, Laminaria Japonica Extract, Pearl Extract, Pentylene Glycol, Hizikia Fusiforme Extract, Caprylyl Glycol, Ulva Australis Extract, Spirulina Maxima Extract, Hydrolyzed Collagen, Ecklonia Cava Extract, Undaria Pinnatifida Extract, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Guaiazulene Sulfonate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Raspberry Ketone, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Copper Tripeptide-1, sh-Decapeptide-7, sh-Octapeptide-4, sh-Oligopeptide-9, sh-Pentapeptide-19, Fragrance, Linalool, Citronellol, Limonene
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 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.JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene NIACINAMIDE BUTYLENE GLYCOL ETHOHEXADIOL .ALPHA.-TOCOPHEROL ACETATE PEA PENTYLENE GLYCOL ARTHROSPIRA MAXIMA POLYSORBATE 80 BENZYL GLYCOL GLYCERIN PANTHENOL ARGININE XANTHAN GUM CAULERPA LENTILLIFERA EXTRACT LAMINARIA JAPONICA EXTRACT ULVA AUSTRALIS ECKLONIA CAVA DIMETHYLSILANOL HYALURONATE SODIUM GUALENATE RASPBERRY KETONE SODIUM ACETYLATED HYALURONATE BUTYLOCTYL SALICYLATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL BEHENYL ACRYLATE POLYMER ETHYLHEXYLGLYCERIN ADENOSINE SARGASSUM FUSIFORME EXTRACT UNDARIA PINNATIFIDA SODIUM HYALURONATE PREZATIDE COPPER POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SODIUM CHLORIDE GLYCERYL STEARATE SE .BETA.-CITRONELLOL, (R)- LIMONENE, (+)- WATER HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE DIPROPYLENE GLYCOL LINALOOL, (+/-)-
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.JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • on damaged skin or broken skin
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 from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • keep out of eyes. Rinse with water to remove.
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
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