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| Product NDC Code | 15751-3504 | ||||
|---|---|---|---|---|---|
| Drug Name | Eminence bright skin starter set kit |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Eminence Organic Skin Care | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 20% 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 Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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: Sun Protection Measures 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 Organic Phytonutrient Blend [Aloe Barbadensis (Aloe) Juice, Glycyrrhiza Glabra (Licorice) Root Extract*, Citrus Limon (Lemon) Peel Extract*, Cymbopogon Schoenanthus (Lemongrass) Extract*, Salix Alba (Willow) Bark Extract*, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract*, Mentha Piperita (Peppermint) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Salvia Officinalis (Sage) Extract*, and Vegetable Glycerin], Persea Gratissima (Avocado) Oil*, Hypoxis Rooperi (African Potato) Extract, Vegetable Glycerin*, Aloe Barbadensis (Aloe) Juice*, Butyrospermum Parkii (Shea Butter)*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Sempervivum Tectorum (Stone Crop) Extract*, Glyceryl Stearate, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, Com-Derived Methyl Glucose Sesquistearate, Soy Lecithin, Polyhydroxystaric Acid, Xanthan Gum, Lactic Acid, Ascorbyl Palmitate (Vitamin C Ester), Citrus Limon (Lemon) Oil, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Chlorophyl, Sodium Benzoate, Potassium Sorbate, Sodium Phytate, Sodium PCA, Blocomplex2 (Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Embica Officinalis (Indian Gooseberry)*, Adansonia Digitata (Baobab)*, Myrciaria Dubia (Camu Camu)*, Daucus Carota Sativa (Carrot)*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Berry*, Tapioca Starch (from Cassava Root)*, Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)]. *Certified organic ingredient
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 ), decreases the risk of skin cancer and early skin aging caused by sun Directions
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.Eminence Bright Skin Starter Set Kit ZINC OXIDE Eminence Bright Skin Moisturizer SPF 40 ZINC OXIDE ALOE VERA LEAF LEMON CYMBOPOGON SCHOENANTHUS TOP SALIX ALBA BARK ARCTOSTAPHYLOS UVA-URSI LEAF MENTHA PIPERITA LEAF ROSEMARY SAGE GLYCERIN AVOCADO OIL SHEA BUTTER CETOSTEARYL ALCOHOL SODIUM CETOSTEARYL SULFATE COCOYL CAPRYLOCAPRATE GLYCERYL MONOSTEARATE MALVA SYLVESTRIS FLOWERING TOP PRIMULA VERIS WHOLE ALCHEMILLA XANTHOCHLORA FLOWERING TOP MELISSA OFFICINALIS LEAF ACHILLEA MILLEFOLIUM WHOLE PANTHENOL HYALURONATE SODIUM LECITHIN, SOYBEAN XANTHAN GUM LACTIC ACID ASCORBYL PALMITATE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID CHLOROPHYLL SODIUM BENZOATE POTASSIUM SORBATE PHYTATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE ACAI CARROT COCONUT WATER STARCH, TAPIOCA THIOCTIC ACID UBIDECARENONE ZINC OXIDE ZINC CATION
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.Package Labeling:Kit Kit
Package Labeling:15751-3505-1 Label40ml
Non Drug Components Non Drug1 Non Drug2 Non Drug3
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
Other information Protect the product in this container from excessive heat and direct sun
Note Store in controlled temperatures (4–20°C/39–68°F). Keep in a dark and dry place. Keep container tightly closed. Do not use if seal under cap is broken or missing.
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 swallowed, 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 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
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 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