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| Product NDC Code | 75936-361 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | (re)setting refreshing mist spf 40 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Supergoop, 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 ingredients Purpose Avobenzone 2.9% Sunscreen Homosalate 9.8% Sunscreen Octisalate 4.9% Sunscreen Octocrylene 9.5% Sunscreen
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.Apply generously and evenly 15 minutes before sun exposure reapply: after 40 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 protection measures including: • limit your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •Children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Alcohol Denat., Bisabolol, Brassica Camprestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for use.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
Spl product data elements
Usually a list of ingredients in a drug product.(Re)Setting Refreshing Mist SPF 40 Avobenzone, Homosalate, Octisalate, Octocrylene ALCOHOL DIHEPTYL SUCCINATE LEVOMENOL BUTYLOCTYL SALICYLATE ETHYL FERULATE LAUROYL LYSINE DIETHYLHEXYL SYRINGYLIDENEMALONATE SPEARMINT OIL ROSEMARY OIL NYLON-12 MEDIUM-CHAIN TRIGLYCERIDES POVIDONE, UNSPECIFIED PEPPERMINT OIL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DICAPRYLYL CARBONATE ISODODECANE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE
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.Supergoop! (Re) Setting Refreshing Mist SPF 40 Broad Spectrum Sunscreen SPF 40 PA+++ Water & Sweat Resistant (40 minutes) 3.4 fl. oz. / 100 ml. Re setting refreshing mist SPF 40
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
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.
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