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Product NDC Code | 62742-4209 | ||||
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Drug Name | Broad spectrum spf30 mineral sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
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 (non-nano) 21 %
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 generously 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures. Spending lime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with abroad Spectrum SPF value of 15 or higher and other sun protet-Wn measures including Limit time in the sun, especial& from 10 arn.-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 Water (Aqua) Caprylic/Capric Triglyceride Coconut Alkanes Cetearyl Alcohol Glycerin Coco-Glucoside Squalane Butyrospermum Parkii Nut Extract Aloe Barbadensis Leaf Juice Cetearyl Glucoside Coco-Caprylate/Caprate Caprylyl/Capryl Glucoside Hydrolyzed Jojoba Esters Cucumis Sativus (Cucumber) Fruit Extract sr-Hydrozoan Polypeptide-1 Polyhydroxystearic Acid Polyglyceryl-3 Polyricinoleate Isostearic Acid Lecithin SodiuM Ascorbyl Phosphate Sclerotium Gum Xanthan Gum Ethylhexylglycerin Sodium Phytate Tocopheryl Acetate Phenoxyethanol Sodium Benzoate
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.Broad Spectrum SPF30 Mineral Sunscreen Zinc Oxide COCO GLUCOSIDE SHEANUT ALOE VERA LEAF COCO-CAPRYLATE/CAPRATE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE SODIUM ASCORBYL PHOSPHATE BETASIZOFIRAN XANTHAN GUM HYDROLYZED JOJOBA ESTERS (ACID FORM) CUCUMBER POLYHYDROXYSTEARIC ACID (2300 MW) LECITHIN, SOYBEAN CETOSTEARYL ALCOHOL GLYCERIN PHYTATE SODIUM .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL SODIUM BENZOATE ETHYLHEXYLGLYCERIN ZINC OXIDE ZINC OXIDE CETEARYL GLUCOSIDE COCONUT ALKANES POLYGLYCERYL-3 PENTARICINOLEATE SQUALANE WATER MEDIUM-CHAIN TRIGLYCERIDES ISOSTEARIC ACID
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.BS SPF30 mineral sunscreen
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 swadlowed 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 conitainer from excessive heat and direct sun May stain some fabrics
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 eye 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