FDA.reportPublic FDA data

Shamrock Sun SPF50

Manufacturer
Shamrock Sun, LLC
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:40

Label at a glance#

ProductShamrock Sun SPF50 Sunscreen
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure11 sections

Storage and handling

Other information protect this product from excessive heat and direct sun may stain some fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%, Homosalate 10%, Octislate 5%, Octocrylene 5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

INACTIVE INGREDIENT SECTION

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 SECTION

Questions?

1-833-286-2789

SPL UNCLASSIFIED SECTION

Distributed by: Shamrock Sun, LLC

Chalfont, PA 18914

www.shamrocksun.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHAMROCK SUN

SUNSCREEN

Broad Spectrum SPF 50

50

Water Resistant (80 Minutes)

32 fl oz (946 mL)

Shamrock Sun Final 2021-01-05Shamrock Sun Final 2021-01-05

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80975-001-322025-01-30C16284748780-12cef2736-5ff3-d83d-e063-dadaa90ab31fSHAMROCK SUN SPF 50 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80975-001-32Shamrock Sun SPF50Sunscreen946 mL in 1 BOTTLELOTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80975-001SHAMROCK SUN SPF50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SHAMROCK SUN, LLC]1Legacy NDC, 1 package rows20210203_b9c21d5f-ef3d-1ab8-e053-2a95a90a99b9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80975-00180975-001-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 207T1F30V5YHIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
COCOA BUTTER512OYT1CRRIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b9c21d5f-ef3c-1ab8-e053-2a95a90a99b9b9c21d5f-ef3d-1ab8-e053-2a95a90a99b92021-01-25WarningsExact identifier
spl id: b9c21d5f-ef3c-1ab8-e053-2a95a90a99b9
spl set id: b9c21d5f-ef3d-1ab8-e053-2a95a90a99b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.