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Product NDC Code | 84568-552 | ||||
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Drug Name | New kid on the block |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Dimples Bath Co. LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 19.6%
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 Directions • Apply liberally 15 minutes before sun exposure • Reapply after 80 minutes of 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 value of 15 or higher and other sun protecting measures including • Limit time in the sun, especially from 1Oam - 2pm 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.Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, , Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water
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 measured (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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.New Kid on the Block Zinc Oxide CELLULOSE GUM ARACHIDYL GLUCOSIDE ARACHIDYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) BUTYLOCTYL SALICYLATE SODIUM HYALURONATE SODIUM STEAROYL GLUTAMATE METHYL DIHYDROABIETATE BUTYROSPERMUM PARKII (SHEA) BUTTER TOCOPHEROL BETA-SITOSTEROL CETEARYL ALCOHOL ZINC OXIDE ZINC OXIDE CITRIC ACID ETHYLHEXYLGLYCERIN COCOS NUCIFERA (COCONUT) OIL MICROCRYSTALLINE CELLULOSE SQUALENE THEOBROMA CACAO (COCOA) SEED BUTTER SODIUM GLUCONATE BISABOLOL HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL COCO-GLUCOSIDE BEHENYL ALCOHOL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) WATER PHENOXYETHANOL DIHEPTYL SUCCINATE CETYL ALCOHOL
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.SPF 50 Lotion
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.If swallowed, get medical help or contact a Poison Control Center immediately
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Protect this product from excessive hear and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.212-627-0377 M-F 9am to 5pm EST
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.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