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Product NDC Code | 46007-204 | ||||
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Drug Name | Skinsuit face spf 50 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Skin Authority LLC | ||||
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 ZINC OXIDE 12%
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 EVENLY TO FACE 15 MINUTES BEFORE EXPOSURE. REAPPLY EVERY 2 HOURS REAPPLY AS NEEDED AFTER SWIMMING OR PERSPIRING CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.WATER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, ISODODECANSE, LAURYL PEG-8 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, OCTYLDODECYL NEOPENTANOATE, PROPANEDIOL, DIMETHICONE, CAPRYLYL METHICONE, NIACINAMIDE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, TRILAURETH-4 PHOSPHATE, ALLANTOIN, BISABOLOL, CAPRYL GLYCOL, ETHYHEXYLGLYCERIN, HEXYLENE GLYCOL, IRON OXIDES, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, PEG-10, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL.
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 WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY 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.SKINSUIT FACE SPF 50 ZINC OXIDE WATER ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE ISODODECANE PEG-8 DIMETHICONE POLYMETHYLSILSESQUIOXANE (11 MICRONS) OCTYLDODECYL NEOPENTANOATE PROPANEDIOL DIMETHICONE CAPRYLYL TRISILOXANE NIACINAMIDE DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) TRILAURETH-4 PHOSPHATE ALLANTOIN .ALPHA.-BISABOLOL, (+)- CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL FERRIC OXIDE RED PEG-10 DIMETHICONE (600 CST) POLYETHYLENE GLYCOL 500 PHENOXYETHANOL SODIUM CHLORIDE SODIUM HYDROXIDE TETRASODIUM GLUTAMATE DIACETATE TOCOPHEROL ZINC OXIDE ZINC CATION
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.0-LBL_SkinSuit Face SPF-50
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.SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF 15+ AND OTHER SUN PROTECTION MEASURES LIMIT TIME IN THE SUN FROM 10AM - 2PM WEAR LONG SLEEVED SHIRT, PANTS, HATS, AND SUNGLASSES
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? 1-866-325-7546 MONDAY - FRIDAY (9 A.M. TO 5 P.M. PST)
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. STORE AT 40° - 95°F (5° - 35°C).
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 BROKEN SKIN SERIOUS BURNS WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS
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