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| Product NDC Code | 62742-4241 | ||||
|---|---|---|---|---|---|
| Drug Name | 6000x elemental screen bs spf 30 sunscreen |
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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 18.9%
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 • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months: Ask a doctor • Reapply: • after 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am - 2pm • wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid, Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)
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 to 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.6000X Elemental Screen BS SPF 30 Sunscreen Zinc Oxide SORBITAN MONOSTEARATE GARDENIA JASMINOIDES FRUIT ALMOND OIL ALOE VERA LEAF LECITHIN, SOYBEAN PHYTATE SODIUM ISOSTEARIC ACID CETYL ALCOHOL NIACINAMIDE TOTAROL PHORMIUM TENAX SEED OIL CARRAGEENAN ZINC OXIDE ZINC OXIDE CETEARYL GLUCOSIDE GLYCERIN PUNICA GRANATUM ROOT BARK BENZYL ALCOHOL WATER FERULIC ACID TOCOPHEROL HONEY STEARIC ACID MEDIUM-CHAIN TRIGLYCERIDES ASTAXANTHIN STEARYL ALCOHOL XANTHAN GUM POLYSORBATE 60 POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 PENTARICINOLEATE DEHYDROACETIC 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.6000X elemental Screen BS SPF 30 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 product is 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 this product from excessive heat or direct sun.
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 • 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