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| Product NDC Code | 14268-119 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Essence light sunscreen spf 50 pa |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | ENGLEWOOD LAB, 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 AVOBENZONE 3.0% HOMOSALATE 9.0% OCTISALATE 4.5% OCTOCRYLENE 5.0% Purpose 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 Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating: Immediately after towel drying At least every 2 hours 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 a.m.– 2 p.m.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER (AQUA), DIPROPYLENE GLYCOL, METHYL METHACRYLA CROSSPOLYMER, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CETEARETH-20, ETHYLHEXYL METHOXYCRYLENE, ACRYLATES COPOLYMER, GALACTOMYCES FERMENT FILTRATE, SACCHAROMYCES FERMENT FILTRATE, CERAMIDE NP, HYDROLYZED HYALURONIC ACID, SODIUM ACETYLATED HYALURONATE, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, POTASSIUM HYALURONATE, PANAX GINSENG ROOT EXTRACT, SORBITAN OLEATE, POLYSORBATE 60, SORBITAN STEARATE, CAPRYLYL GLYCOL, CETEARYL OLIVATE, PANTHENOL, SODIUM HYALURONATE, GLYCERIN, SORBITAN OLIVATE, ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TROMETHAMINE, SODIUM ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATECOPOLYMER, ISOHEXADECANE, AMMONIUM ACRYLOYLMETHYLTAURATE/ VP COPOLYMER, 1,2-HEXANEDIOL,BHT,ETHYLHEXYLGLYCERIN, POLYSORBATE 80, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, XANTHAN GUM, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPY-LTRIMONIUM HYALURONATE, POTASSIUM SORBATE, HYDROGENATED LECITHIN, SODIUMBENZOATE, OCTYLDODECANOL
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.ESSENCE LIGHT SUNSCREEN SPF 50 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WATER DIPROPYLENE GLYCOL PROPYLENE GLYCOL BUTYLOCTYL SALICYLATE POLYOXYL 20 CETOSTEARYL ETHER ETHYLHEXYL METHOXYCRYLENE CERAMIDE NP SODIUM ACETYLATED HYALURONATE HYALURONIC ACID ASIAN GINSENG SORBITAN MONOOLEATE POLYSORBATE 60 SORBITAN MONOSTEARATE CAPRYLYL GLYCOL CETEARYL OLIVATE PANTHENOL HYALURONATE SODIUM GLYCERIN SORBITAN OLIVATE TROMETHAMINE ISOHEXADECANE 1,2-HEXANEDIOL BUTYLATED HYDROXYTOLUENE ETHYLHEXYLGLYCERIN POLYSORBATE 80 TRISODIUM ETHYLENEDIAMINE DISUCCINATE XANTHAN GUM BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM SORBATE SODIUM BENZOATE OCTYLDODECANOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Package Labeling:10ml Outer Package2 Inner Package2
Package Labeling:50ml Label01.jpg
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.Drug Facts
Other information • Protect the product in this container from excessive heat and direct sun
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 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.
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. 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. Keep out of reach of children. 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