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Product NDC Code | 43479-209 | ||||||||||
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Drug Name | Daily deflector mineral sunscreen spf 40 |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | LOTION | ||||||||||
Application Number | M020 | ||||||||||
Labeler Name | KATE SOMERVILLE SKINCARE LLC | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 17%
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 IMMEDIATELY AFTER TOWEL DRYING 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. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS AQUA/WATER/EAU, ISOAMYL LAURATE, POLYMETHYLSILSESQUIOXANE/SILICA CROSSPOLYMER, GLYCERIN, UNDECANE, ISODODECANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, COCOGLYCERIDES, TRIDECANE, SODIUM CHLORIDE, LAURYL PEG-9, POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, ETHYLHEXYL METHOXYCRYLENE, ECTOIN, TASMANNIA LANCEOLATA FRUIT/LEAF EXTRACT, HYDROXYECTOIN, CERAMIDE NP, TOCOPHERYL ACETATE, DISTEARDIMONIUM HECTORITE, COCONUT ALKANES, 1,2-HEXANEDIOL, PROPYLENE CARBONATE, SODIUM LAUROYL LACTYLATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CAPRYLHYDROXYAMIC ACID, COCO-CAPRYLATE/CAPRATE, CHOLESTEROL, XANTHAN GUM, CARBOMER, SODIUM CITRATE
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 DEFLECTOR MINERAL SUNSCREEN SPF 40 ZINC OXIDE ALCOHOL ISOBUTANE PROPANE ISODODECANE ETHYLHEXYL METHOXYCRYLENE POVIDONE, UNSPECIFIED METHYL DIHYDROABIETATE HYALURONIC ACID RHODIOLA ROSEA ROOT WATER LAVENDER OIL SILICA, TRIMETHYLSILYL CAPPED PENTYLENE GLYCOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE
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.01b UC_Daily Deflector Mineral Sunscreen_50mL
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? VISIT WWW.KATESOMERVILLE.COM OR CALL 1-800-984-5283.
Storage and handling
Information about safe storage and handling of the drug product.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.
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