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| Product NDC Code | 36800-513 | ||||
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| Drug Name | Beauty hydrating |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Topco | ||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 © TOPCO VIJA0724 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Homosalate 5.0% Zinc oxide 3.0%
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 apply to all skim exposed to the sun reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 highter and other sun protection measures including: limit the 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, tocopheryl acetate, Aloe barbadensis leaf extract, steareth-21, stearyl alcohol, caprylyl glycol, behenyl alcohol, phenoxyethanol, cetyl alcohol, fragrance, hydroxyacetophenone, disodium EDTA, steareth-2, oleth-3 phosphate
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 rise 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.Beauty Hydrating Homosalate, Zinc Oxide WATER GLYCERIN ISOHEXADECANE SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) POLYSORBATE 80 LAURETH-7 CYCLOMETHICONE 5 CYCLOMETHICONE 6 .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF STEARETH-21 STEARYL ALCOHOL CAPRYLYL GLYCOL DOCOSANOL PHENOXYETHANOL CETYL ALCOHOL HYDROXYACETOPHENONE EDETATE DISODIUM STEARETH-2 OLETH-3 PHOSPHATE HOMOSALATE HOMOSALATE ZINC OXIDE ZINC CATION
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.principal display panel - side panels Top Care ® beauty ALL-DAY MOISTURIZER Sunscreen Lotion ALL-DAY MOISTURE Formulated with Vitamin E and nourishing beauty moisture that absorbs quickly into skin and lasts all day to help your skin stay soft, smooth and beautiful. UV PROTECTION Broad-spetrum UVA and UVB protection with SPF 15 to help prevent premature skin damage QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed. Top Care ® beauty ALL-DAY MOISTURIZER Sunscreen Lotion Light, non-greasy formula Non-comedogenic (won't clog pores) Phthalate free Light, fast absorbing moisture lasts all day Softens and smoothes for radiant-looking skin
principal display panel Top Care ® beauty ALL-DAY MOISTURIZER Sunscreen Lotion For Normal Skin Compare to OLAY ® * Broad spectrum SPF 15 Dermatologist tested SPF 15 6 FL OZ (177mL) image description
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.Disclaimer *This product is not manufactured or distributed by Procter & Gamble, distributor of Olay ® Complete UC365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 15 Normal. May stain or damage some fabrics or surfaces.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the 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
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