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| Product NDC Code | 71014-038 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Beach break 2-in-1 daily facial moisturizer sunscreen spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | EAI-JR 286 | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Homosalate 8% Sunscreen Octisalate 5% Avobenzone 3% Octocrylene 2%
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 and at least every 2 hours Reapply: After 40 minutes of swimming or sweating 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 Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeve 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 Water (Aqua), Diisopropyl Adidpate, Dicaprylyl Ether, Pentylene Glycol, Stearyl/octyldodecyl Citrate Crosspolymer, Glycerin, Cetyl Alcohol, Potassium Cetyl Phosphate, Phenoxyethanol, Glyceryl Caprylate, Sodium Polyacrylate, Cetearyl Olivate, Sorbitan Olivate, Ferulic Acid, Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Limonene, Caprylhydroxamic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Niacinamide, Sodium Gluconate, Aminomethyl Propanol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Jasminum Officinale (Jasmine) Extract, Linalool, Tocopherol, Eugenia Caryophyllus (Clove) Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract, Vitis Vinifera (Grape) Fruit Extract, Glycine Soja (Soybean) Oil
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.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 Higher SPF gives more sunburn protection Retains SPF after 40 minutes activity in the water, sweating, or perspiring Provides high protection against sunburn
Spl product data elements
Usually a list of ingredients in a drug product.Beach Break 2-in-1 Daily Facial Moisturizer Sunscreen SPF 30 Homosalate, Octisalate, Avobenzone, Octocrylene WATER DICAPRYLYL ETHER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES LIMONENE, (+)- SODIUM GLUCONATE STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER SODIUM POLYACRYLATE (8000 MW) CETEARYL OLIVATE FERULIC ACID LINALOOL, (-)- NIACINAMIDE AMINOMETHYLPROPANOL OCTOCRYLENE OCTOCRYLENE DIISOPROPYL ADIPATE PENTYLENE GLYCOL CAPRYLHYDROXAMIC ACID TETRAHEXYLDECYL ASCORBATE OCTISALATE OCTISALATE CETYL ALCOHOL GLYCERYL CAPRYLATE ETHYLHEXYLGLYCERIN AVOBENZONE AVOBENZONE POTASSIUM CETYL PHOSPHATE PHENOXYETHANOL SORBITAN OLIVATE HOMOSALATE HOMOSALATE SOYBEAN OIL TOCOPHEROL LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP WINE GRAPE
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.Vertra 30 Beach Break Daily Facial Moisturizer Broad Spectrum SPF 30 Water Resistant (40 minutes) 1.6 FL OZ / 45.36 mL Beach break outer
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
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 or damaged skin When using this product keep out of eyes If product is swallowed, get medical help or contact a Poison Control Center right away
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