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| Product NDC Code | 69455-463 | ||||
|---|---|---|---|---|---|
| Drug Name | Drunk elephant umbre tinte physical daily defense protection spf-30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Drunk Elephant, 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 Ingredient Zinc Oxide 20%
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 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 the 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. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, caprylic/capric triglyceride, dicaprylyl carbonate, glycerin, pentylene glycol, steareth-2, propanediol, steareth-21, polyhydroxystearic acid, cetearyl alcohol, silica, sclerocarya birrea seed oil, aloe barbadensis leaf extract, chondrus crispus extract, haematococcus pluvialis extract, helianthus annuus (sunflower) sprout extract, vitis vinifera (grape) juice extract, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, raspberry seed oil/tocopheryl succinate aminopropanediol esters, hydrolyzed wheat protein, tocopheryl acetate, tocopherol, sea water, acetyl glucosamine, cetearyl glucoside, sodium stearoyl glutamate, tetrahexyldecyl ascorbate, glycine, sucrose, lecithin, triethoxycaprylylsilane, xanthan gum, trisodium ethylenediamine disuccinate, caprylhydroxamic acid, caprylyl glycol, sodium C14-16 olefin sulfonate, phenoxyethanol, chlorphenesin, sodium dehydroacetate, iron oxides (CI 77491, CI 77492, CI 77499)
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.Drunk Elephant Umbre Tinte Physical Daily Defense Protection SPF-30 Zinc Oxide ZINC OXIDE Zinc Oxide WATER MEDIUM-CHAIN TRIGLYCERIDES DICAPRYLYL CARBONATE GLYCERIN PENTYLENE GLYCOL STEARETH-2 PROPANEDIOL STEARETH-21 POLYHYDROXYSTEARIC ACID (2300 MW) CETOSTEARYL ALCOHOL SILICON DIOXIDE SCLEROCARYA BIRREA SEED OIL ALOE VERA LEAF CHONDRUS CRISPUS HAEMATOCOCCUS PLUVIALIS HELIANTHUS ANNUUS SPROUT WINE GRAPE JUICE SUNFLOWER OIL JOJOBA OIL RASPBERRY SEED OIL HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) .ALPHA.-TOCOPHEROL SUCCINATE, D- AMINOPROPANEDIOL .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL SODIUM CHLORIDE N-ACETYLGLUCOSAMINE CETEARYL GLUCOSIDE SODIUM STEAROYL GLUTAMATE TETRAHEXYLDECYL ASCORBATE GLYCINE SUCROSE SODIUM C14-16 OLEFIN SULFONATE LECITHIN, SUNFLOWER TRIETHOXYCAPRYLYLSILANE XANTHAN GUM TRISODIUM ETHYLENEDIAMINE DISUCCINATE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL PHENOXYETHANOL CHLORPHENESIN SODIUM DEHYDROACETATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TAN
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 - 60 ml Tube Box EST D 2012 DRUNK ELEPHANT ™ Umbra Tinte ™ Physical Daily Defense PROTECT + GLOW SUNSCREEN BROAD SPECTRUM SPF 30 20% Zinc Oxide Sunflower Shoot Extract 60 ml / 2 fl oz PRINCIPAL DISPLAY PANEL - 60 ml Tube Box
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
Dist. by: Drunk Elephant ® Newport Beach, CA 92663, USA
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.Questions or Comments 800.604.1795
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 this 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 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 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