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| Product NDC Code | 62742-4245 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Daily prevention pure mineral hydrating moisturizer spf30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Allure Labs | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients : Zinc Oxide 18.1%
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 generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water /Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Dimethicone, Glycerin, Lecithin, Isohexadecane, Aloe Barbadensis Leaf Juice, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Magnesium Sulfate Heptahydrate, Acetyl Zingerone, Phenoxyethanol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Camellia Sinensis Leaf Extract, Methyl Propanediol, Sodium Hyaluronate, Polysorbate 60,Ectoin,Sodium Citrate,Sorbitan Isostearate, Tocopherol, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate
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.Daily Prevention Pure Mineral Hydrating Moisturizer SPF30 Zinc Oxide STEARIC ACID POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES ISOHEXADECANE TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) POLYSORBATE 60 SORBITAN ISOSTEARATE PALMITIC ACID TETRAHEXYLDECYL ASCORBATE ZINC OXIDE ZINC OXIDE PHENOXYETHANOL ACETYL ZINGERONE HEXYLENE GLYCOL MANNITOL VANILLA POTASSIUM SORBATE TOCOPHEROL WATER DIMETHICONE/PEG-10/15 CROSSPOLYMER MAGNESIUM SULFATE HEPTAHYDRATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) LECITHIN, SOYBEAN ALOE VERA LEAF HAEMATOCOCCUS PLUVIALIS PHENYLPROPANOL SODIUM BENZOATE SODIUM CITRATE DICAPRYLYL CARBONATE HYALURONATE SODIUM CYCLOMETHICONE 5 DIMETHICONE GLYCERIN ETHYLHEXYLGLYCERIN METHYLPROPANEDIOL PANTHENOL SQUALANE PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 GREEN TEA LEAF ECTOINE
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.DP Pure Mineral hydrating moist SPF30
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients , this product may change in color over time.
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
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