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| Product NDC Code | 76159-234 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 3lab perfect lite sunscreen spf 30 broad spectrum |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | 3LAB, 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 TITANIUM DIOXIDE 2.48% ZINC OXIDE 6.00%
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.PERFECT Lite Sunscreen SPF 30 Clinically proven, this advanced physical sunscreen goes on smooth, clean and light to defend the skin against harmful UV rays. Containing ingredients found in nature, it is oil, PABA and fragrance-free - ideal for all skin types including sensitive skin. Micronized Titanium Dioxide and Zinc Oxide work immediately to help prevent the harmful effects of the sun including sunburn, skin damage, freckling and discoloration. Also helps prevent heat buildup on skin. Just Perfect!
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 Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor Apply to all skin exposed to the sun
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, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Panthenol, Allantoin, Disodium EDTA, Lauryl PEG-9 Polydiemthylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin.
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.3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE CETYL ALCOHOL PROPYLENE GLYCOL TRIETHOXYCAPRYLYLSILANE ALOE VERA LEAF PANTHENOL ALLANTOIN EDETATE DISODIUM BUTYLENE GLYCOL CHAMOMILE GREEN TEA LEAF ALUMINUM OXIDE PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER ETHYLHEXYL PALMITATE CYCLOMETHICONE DIMETHICONE GLYCERYL MONOSTEARATE PEG-100 STEARATE ALKYL (C12-15) BENZOATE POLYSORBATE 80 ISOHEXADECANE
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.InnerLabel OuterLabel
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.on damaged or broken skin. Do not use
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 product is 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 this product from excessive heat and direct sun
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum TITANIUM DIOXIDE 2.48% ZINC OXIDE 6.00%
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.if rash occurs. Stop use and ask a doctor
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.keep out of eyes. Rinse with water to remove. When using this product
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