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| Product NDC Code | 52257-1400 | ||||
|---|---|---|---|---|---|
| Drug Name | Atomy derma calming sun |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | ATOMY CO., LTD. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Titanium Dioxide 8.86%
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 • Children under 6 months: Ask a doctor • 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.INACTIVE INGREDIENTS ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, SYNTHETIC FLUORPHLOGOPITE, C12-15 ALKYL BENZOATE, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PHENYL TRIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL METHICONE, OZOKERITE, VINYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, CALAMINE, ALUMINUM STEARATE, ALUMINA, CITRUS AURANTIUM DULCIS (ORANGE) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDR OXYSTEARATE/SEBACATE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DEHYDROACETIC ACID, LITSEA CUBEBA FRUIT OIL, OCTYLDODECANOL, DIOSPYROS KAKI LEAF EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, GLYCERIN, AQUA/WATER/EAU, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, PANCRATIUM MARITIMUM EXTRACT
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.ATOMY DERMA CALMING SUN Titanium Dioxide Titanium Dioxide TITANIUM DIOXIDE ISOPROPYL PALMITATE ETHYLHEXYL PALMITATE
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 LABEL.PRINCIPAL DISPLAY PANEL Image of carton
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 and direct sun
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 product is 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