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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Avobenzone 2%, Octisalate 5%, Octocrylene 2%

Purpose

Sunscreen

Uses

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.

Directions And Dosage

Directions

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.

Other Label Information

Inactive Ingredients

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

Questions or comments?

Email info@supplyaccy.com

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

Label Images#

cf595443-f11a-6294-e053-2a95a90a8c84
cf595443-f11a-6294-e053-2a95a90a8c84
58443-0432-4
58443-0432-4

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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-043258443-0432-4

Ingredients#

Complete SPL Sections#

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.

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

Source Document#

Source XML