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| Product NDC Code | 41520-940 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | American Sales Company | ||||||||
| 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 3% Homosalate 10% Octisalate 4.5% Octocrylene 8%
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 ■ apply to all skin exposed to the sun ■ 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 protection measures including: ■ limit 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 water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, fragrance, benzyl alcohol, disodium EDTA
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.Use helps prevent sunburn if used as directed with other sun protections measures (see Directions ), decreases the rist 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.SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE water GLYCERIN ALUMINUM STARCH OCTENYLSUCCINATE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) POLYESTER-7 SILICON DIOXIDE CHLORPHENESIN ARACHIDYL ALCOHOL YELLOW WAX neopentyl glycol diheptanoate CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) DOCOSANOL tocopherol ARACHIDYL GLUCOSIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE POTASSIUM HYDROXIDE BENZYL ALCOHOL EDETATE DISODIUM ANHYDROUS
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 Panel Display Care One Compare to Coppertone sunscreen Lotion Ultra Guard SPF 50* SUNSCREEN LOTION SPF 50 UVA/UVB protection BROAD SPECTRUM SPF 50 Water-Resistand (80 minutes) Enriched with moisturizers Hypoallergenic Reef friendly 8 FL OZ (236 mL) image description
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.Other information Protect the product from excessive heat and direct sun
May stain or damage some fabrics or surfaces Dist by Foolhold USA, LLC Landover, MD 20785 1-877-848-8949 (c) S&S Brands, LLC Quality guraranteed or your money back. *This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50. *Oxybenzone & Octinoxate Free
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 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 of eyes. Rinse with water to remove
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
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