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| Product NDC Code | 76187-850 | ||||
|---|---|---|---|---|---|
| Drug Name | Isa sunguard spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Isagenix International, LLC | ||||
| 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 Zinc Oxide 6.0%.......................................Sunscreen Titanium Dioxide 2.3%..............................Sunscreen
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays. Manufactured for Isagenix International LLC, Distributed by Isagenix International LLC AZ 85286 USA. Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada 3900949.000-00 Item #40040
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 before sun exposure to the sun. - Reapply after excessive perspiration or swimming. - Ask a doctor before use on children under 3 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua/Eau), Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Polysorbate 80, Caprylyl Methicone, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethoxysilyllethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Glycerin, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Algae Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorophenesin
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 Higher SPF gives more sunburn protection
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn Higher SPF gives more sunburn protection
Spl product data elements
Usually a list of ingredients in a drug product.Isa SunGuard SPF 30 ZINC OXIDE, TITANIUM DIOXIDE WATER ETHYLHEXYL PALMITATE CYCLOMETHICONE DIMETHICONE GLYCERYL MONOSTEARATE PEG-100 STEARATE ALKYL (C12-15) BENZOATE POLYSORBATE 80 ISOHEXADECANE CETYL ALCOHOL PROPYLENE GLYCOL DIETHYLHEXYL CARBONATE TRIETHOXYCAPRYLYLSILANE ALOE VERA LEAF PANTHENOL ALLANTOIN EDETATE DISODIUM GLYCERIN BUTYLENE GLYCOL CHAMOMILE GREEN TEA LEAF GLYCYRRHIZA GLABRA ALUMINUM OXIDE POLYHYDROXYSTEARIC ACID (2300 MW) PHENOXYETHANOL CAPRYLYL GLYCOL ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Reveal a New You REJUVITY REJUVITY ISAGENIX
Isa SunGuard All-natural SPF 30 Featuring Zinc Oxide and Titanium Dioxide 3.4 OZ (100 ml)
REJUVITY ISAGENIX Isa SunGuard All-natural SPF 30 Featuring Zinc Oxide and Titanium Dioxide 3.4 OZ (100 ml) Rich in Aloe vera gel, green tea and chamomile, this long-lasting, water-resistant facial moisturizer provides optimal broad-spectrum protection from UVA and UVB rays. Manufactured for Isagenix International LLC, Distributed by Isagenix International LLC AZ 85286 USA. Isagenix International ULC, Mississauga, Ontario L4W 1G4 Canada 3901021.000-00
Isa 1
Isa 2
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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 irritated 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.In case of accidental ingestion, 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 physician if rash, irritation or sensitivity develops and lasts.
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 do not ger into eyes. If contact occurs, rinse eyes thoroughly with water.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Other information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the 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