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Product NDC Code | 81110-056 | ||||
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Drug Name | Ilia super serum skin tint (st13.5 rialto) |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Ilia, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 12% 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 For sunscreen use: -Apply liberally 15 minutes before sun exposure. -Reapply at least every 2 hours -Use 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 risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm wear long sleeve 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 AQUA/WATER/EAU, SQUALANE, SHEA BUTTER ETHYL ESTERS, ISOAMYL LAURATE, POLYGLYCERYL-3 RICINOLEATE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, ISOPROPYL ISOSTEARATE, POLYGLYCERYL-3 DIISOSTEARATE, METHYLPROPANEDIOL, NIACINAMIDE, SODIUM CHLORIDE, LECITHIN, CAPRYLYL GLYCOL, SILICA, ALOE BARBADENSIS LEAF JUICE POWDER, BISABOLOL, HYDROLYZED SODIUM HYALURONATE, ALLANTOIN, PHENYLPROPANOL, SODIUM MYRISTOYL GLUTAMATE, SODIUM HYALURONATE, POLYHYDROXYSTEARIC ACID, TETRASODIUM GLUTAMATE DIACETATE, ALUMINUM HYDROXIDE. MAY CONTAIN/PEUT CONTENIR (±): CI 77492, CI 77491, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE).
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.ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO) Zinc Oxide SHEA BUTTER ISOAMYL LAURATE POLYGLYCERYL-3 DIISOSTEARATE ISOPROPYL ISOSTEARATE .ALPHA.-BISABOLOL, (+)- CAPRYLYL GLYCOL LECITHIN, SOYBEAN ALOE VERA LEAF ALLANTOIN SILICON DIOXIDE SQUALANE BUTYLOCTYL SALICYLATE HYALURONATE SODIUM TITANIUM DIOXIDE SODIUM MYRISTOYL GLUTAMATE ALUMINUM HYDROXIDE WATER NIACINAMIDE PROPANEDIOL SODIUM CHLORIDE PHENYLPROPANOL METHYLPROPANEDIOL ZINC OXIDE ZINC OXIDE
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.SSST Rialto
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.DIST. BY ILIA INC LAGUNA BEACH, CA 92651 ILIABEAUTY.COM
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Other Information Protect this product from excessive heat and direct sun. Questions or comments? 1-949-715-9099
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
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 -Stop use and ask a doctor if rash occurs -Keep out of reach of children. If product is 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