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| Product NDC Code | 13630-0232 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Vacation world classic whip spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Prime Packaging Inc. | ||||||||
| 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 Ingredients Homosalate 7.5%, Octisalate 5%, Octocrylene 5%, Avobenzone 3%
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. Dispense a ping pong ball size amount and apply to a single area (arm,leg,chest,or back). Repeat up to 4 times (roughly a tennis ball size amount) for a whole body application. Do not spray product directly on face. Spray onto hands and rub onto face. 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 the 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 10 a.m.- 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses Chidlren under 6 months of age: ask a physician
Other information Protect this product from excessive heat and direct sun
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Microcrystalline Cellulose, Musa Sapientum (Banana) Fruit Extract, Niacinamide, PVP/Hexadecene Copolymer, Phenoxyethanol, Polymethylsilsesquioxane, Polysorbate 20, Sodium Hyaluronate, Stearic Acid, Tapioca Starch, Tetrafluoropropene, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, 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 measures (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.Vacation World Classic Whip SPF 30 Dimethicone COCONUT OIL OCTISALATE OCTISALATE AMINOMETHYLPROPANOL ETHYLHEXYLGLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 NIACINAMIDE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE ALOE VERA LEAF BUTYLOCTYL SALICYLATE STARCH, TAPIOCA TETRASODIUM GLUTAMATE DIACETATE ALPHA-TOCOPHEROL ACETATE WATER DIMETHICONE BANANA HYALURONATE SODIUM STEARIC ACID PHENOXYETHANOL Off-White
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.Vacation World Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse Principle Display Label
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. In case of ingestiion, get medical help or contact a Poison Control Center right away.
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 if 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 fo eyes. Rinse with water to remove. Do not store at temperatures above 120 F.
Use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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 Contents under pressure. Do not puncture or incinerate can. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs When using this product Keep out fo eyes. Rinse with water to remove. Do not store at temperatures above 120 F. Keep out of reach of children. In case of ingestiion, get medical help or contact a Poison Control Center right away. Use only as directed. intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
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