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Drug Facts
Distributed by: Shamrock Sun, LLC
Chalfont, PA 18914
www.shamrocksun.com
Shamrock Sun Spf50
FDA Label NDC 80975-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shamrock Sun, Llc for the product Shamrock Sun Spf50 (NDC 80975-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Avobenzone 3%, Homosalate 10%, Octislate 5%, Octocrylene 5%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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.
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove
Otc - Stop Use
Stop use and ask doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
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.
Storage And Handling
Other information
- protect this product from excessive heat and direct sun
- may stain some fabrics
Inactive Ingredient
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
Otc - Questions
Questions?
1-833-286-2789
Package Label.Principal Display Panel
SHAMROCK SUN
SUNSCREEN
Broad Spectrum SPF 50
50
Water Resistant (80 Minutes)
32 fl oz (946 mL)
* Please review the disclaimer below.
