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| Product NDC Code | 15751-3506 | ||||
|---|---|---|---|---|---|
| Drug Name | Eminence radiant protection spf fluid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | Eminence Organic Skin Care | ||||
| Packages |
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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 Shake well before 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 this 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-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 Caprylic/Capric Triglyceride*, Butyloctyl Salicylate, Oryza Sativa (Rice) Wax*, Copernicia Cerifera (Carnauba) Wax*, Triheptanoin, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Polyhydroxystearic Acid, Lauroyl Lysine, Methyl Glucose Dioleate, Hydrogenated Poly(C6-20 Olefin),HDI/Trimethylol Hexyllactone Crosspolymer, Niacinamide (Vitamin B3), C13-16 Isoalkane, Bakuchiol, Natural Fragrance, Biocomplex2™ [Daucus Carota Sativa (Carrot) Seed Oil*, Euterpe Oleracea (Acai) Fruit Extract*, Citrus Limon (Lemon) Juice*, Malpighia Glabra (Barbados Cherry) Fruit Extract*, Emblica Officinalis (Indian Gooseberry) Fruit Extract*, Adansonia Digitata (Baobab) Fruit Extract*, Myrciaria Dubia (Camu Camu) Fruit Extract*, Daucus Carota Sativa (Carrot) Root Extract*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Fruit Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Plant-Derived Maltodextrin* and Vegetable Glycerin*].
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.Active Ingredient Purpose Zinc Oxide 15%............Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Eminence Radiant Protection SPF Fluid ZINC OXIDE CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE C13-16 ISOPARAFFIN CARNAUBA WAX POLYHYDROXYSTEARIC ACID (2300 MW) ZINC OXIDE ZINC OXIDE TRIHEPTANOIN LAUROYL LYSINE NIACINAMIDE FRAGRANCE 13576 MALPIGHIA GLABRA FRUIT ADANSONIA DIGITATA FRUIT MYRCIARIA DUBIA FRUIT DAUCUS CAROTA SUBSP. SATIVUS WHOLE COCONUT WATER LYCIUM BARBARUM FRUIT BUTYLOCTYL SALICYLATE PENTAERYTHRITYL STEARATE METHYL GLUCOSE DIOLEATE BAKUCHIOL ACAI LEMON STARCH, TAPIOCA THIOCTIC ACID RICE BRAN HYDROGENATED C6-20 POLYOLEFIN (100 CST) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER PHYLLANTHUS EMBLICA FRUIT UBIDECARENONE
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.Radiant Protection SPF Fluid Drug Facts Active Ingredient Purpose Zinc Oxide 15%……………………...Sunscreen 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 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 doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Shake well before 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 this 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-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor. Other information Protect the product in this container from excessive heat and direct sun. Inactive ingredients Caprylic/Capric Triglyceride*, Butyloctyl Salicylate, Oryza Sativa (Rice) Wax*, Copernicia Cerifera (Carnauba) Wax*, Triheptanoin, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Polyhydroxystearic Acid, Lauroyl Lysine, Methyl Glucose Dioleate, Hydrogenated Poly(C6-20 Olefin), HDI/Trimethylol Hexyllactone Crosspolymer, Niacinamide (Vitamin B3), C13-16 Isoalkane, Bakuchiol, Natural Fragrance, Biocomplex2™ [Daucus Carota Sativa (Carrot) Seed Oil*, Euterpe Oleracea (Acai) Fruit Extract*, Citrus Limon (Lemon) Juice*, Malpighia Glabra (Barbados Cherry) Fruit Extract*, Emblica Officinalis (Indian Gooseberry) Fruit Extract*, Adansonia Digitata (Baobab) Fruit Extract*, Myrciaria Dubia (Camu Camu) Fruit Extract*, Daucus Carota Sativa (Carrot) Root Extract*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Fruit Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Plant-Derived Maltodextrin* and Vegetable Glycerin*]. DISTRIBUTED BY Éminence Organic Skin Care #300 - 530 West Broadway, Vancouver BC V5Z 1E9 www.eminenceorganics.com 1-888-747-6342 (US & Canada Toll Free) FORMULATED IN HUNGARY / Made in USA Refer to Radiant Protection SPF Fluid US 1.7oz Radiant Protection SPF Fluid US 1.7oz Box
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 or reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.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 doctor if rash occurs
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