FDA.reportPublic FDA data

Hurley Sunscreen Lotion Broad Spectrum SPF 15

Manufacturer
Prime Enterprises Inc.
Effective date
2021-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:31

Label at a glance#

ProductHurley Broad Spectrum SPF 15 Sunscreen
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and 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.

Dosage and administration

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 of 15 or higher and other sun protection measures including: Limit time in the sun,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octisalate 5%, Octocrylene 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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 SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep put of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.
  • Avoid contact with fabrics - could cause discoloration

Questions or comments?

OTC - QUESTIONS SECTION

Email info@supplyaccy.com

Principle Display Label - Hurley Sunscreen Lotion Broad Spectrum SPF 15 177 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0432-42023-01-30C16284748780-1f386c64a-17d4-0266-e053-dadaa90a7c1aHurley Sunscreen Lotion Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0432-4HurleyBroad Spectrum SPF 15 Sunscreen177 mL in 1 BOTTLELOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0432HURLEY BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20211028_cc1dcfa8-e104-34ee-e053-2995a90a92af.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
58443-043258443-0432-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYPROMELLOSES3NXW29V3WOIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTISALATE4X49Y0596WACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
COCOA BUTTER512OYT1CRRIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
cc1dcfa8-e105-34ee-e053-2995a90a92afcc1dcfa8-e104-34ee-e053-2995a90a92af2021-09-16WarningsExact identifier
spl id: cc1dcfa8-e105-34ee-e053-2995a90a92af
spl set id: cc1dcfa8-e104-34ee-e053-2995a90a92af