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| Product NDC Code | 82757-101 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | The bod guard invisible sunscreen for body |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Dune Suncare, 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 Avobenzone 2.0% Homosalate 5.5% Octisalate 4.5% Octocrylene 4.0%
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 and evenly 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating. at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 time in the sun, especially from 10a.m.-2p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Trisiloxane, Alcohol, Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Polycryloyldimethyl Taurate, Brassica Glycerides, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Caprylhydroxamic Acid, Polysilicone-11, Disodium EDTA, Erythritol, Fragrance, Tocopheryl Acetate, Butylene Glycol, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Hibiscus Sabdariffa Fruit Extract, Decyl Glucoside, t-Butyl Alcohol, Denatonium Benzoate
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 (see Directions ), decrease 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.The Bod Guard Invisible Sunscreen for Body Avobenzone, Homosalate, Octisalate, and Octocrylene Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Water Dimethicone Propanediol Alcohol CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) TRISILOXANE 1,2-Hexanediol Glycerin Aminomethylpropanol Caprylhydroxamic Acid Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) Edetate Disodium Anhydrous Erythritol .Alpha.-Tocopherol Acetate Butylene Glycol Decyl Glucoside DENATONIUM BENZOATE AZADIRACHTA INDICA LEAF AZADIRACHTA INDICA FLOWER CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) TERT-BUTYL 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.PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label THE BOD GUARD INVISIBLE GEL SUNSCARE FOR BODY BROAD SPECTRUM SPF 30 WATER RESISTANT (40 MINUTES) DUNE SUNCARE SPF 30 72 Hour Hydration Won't Clog Pores Dermatologist Approved Scent: Sea Salt 250 ML 8.4 FL OZ Principal Display Panel - 250 ML Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Dist. by: Dune Suncare, Los Angeles, CA 90292
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. If swallowed, get medical help or contact 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 of eyes. Rinse water to remove
Storage and handling
Information about safe storage and handling of the drug product.Other Information protect the product in this container from excessive heat and direct sun
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 damaged or broken skin When using this product keep out of eyes. Rinse water to remove Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact 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