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Shamrock sun spf50 sunscreen - Medication Information

Product NDC Code 80975-001
Drug Name

Shamrock sun spf50 sunscreen

Type Brand
Active Ingredients
Avobenzone 3 g/100ml
Homosalate 10 g/100ml
Octisalate 5 g/100ml
Octocrylene 5 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Shamrock Sun, LLC
Packages
Package NDC Code Description
80975-001-32 946 ml in 1 bottle (80975-001-32)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone 3%, Homosalate 10%, Octislate 5%, Octocrylene 5%

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: shake well before use apply liberally 15 minutes before sun exposure 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: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Propylene Glycol, High Density Polyethylene, C12-15 Alkyl Benzoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Fragrance, Sodium Hydroxide, Disodium EDTA, Hydroxypropyl Methylcellulose, Sorbitan Oleate, Tocopheryl Acetate, Ethylhexylglycerin, Theobroma Cacao (Cocoa) Seed Butter

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 ), 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.
Shamrock Sun SPF50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE SORBITAN MONOOLEATE .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 20 HIGH DENSITY POLYETHYLENE ALKYL (C12-15) BENZOATE PROPYLENE GLYCOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN COCOA BUTTER HYPROMELLOSE, UNSPECIFIED CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE ALOE VERA LEAF WATER EDETATE DISODIUM EDETIC ACID SODIUM HYDROXIDE

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.
SHAMROCK SUN SUNSCREEN Broad Spectrum SPF 50 50 Water Resistant (80 Minutes) 32 fl oz (946 mL) Shamrock Sun Final 2021-01-05

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 Distributed by: Shamrock Sun, LLC Chalfont, PA 18914 www.shamrocksun.com

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 immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-833-286-2789

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 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

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect this product from excessive heat and direct sun may stain some fabrics

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 with water to remove Stop use and ask doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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