OP-SPF50 8oz Sport Cooling Sunscreen Lotion

Manufacturer
SolSkyn Personal Care LLC
Effective date
2018-02-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:29

Label at a glance#

ProductOP spf50 and Sport Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 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. • Re-apply:       • 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 measu...

Storage and handling

• For use on skin only. Avoid contact with fabric. • Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OP spf50+ Sport Sunscreen

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15.0%

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5.0%

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 7.0%

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 on damaged or broken skin.

OTC - DO NOT USE SECTION

• Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

• Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure.

• Re-apply:

      • 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 Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Iodopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Menthol, Phenoxyethanol, Polyester-8, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water

Other Information:

STORAGE AND HANDLING SECTION

• For use on skin only. Avoid contact with fabric.

• Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ocean Potion
Protect
& Nourish
Sport
cooling
SPF 50
8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Nourish Sport cooling SPF 50 8 fl oz (237 mL)PRINCIPAL DISPLAY PANEL Ocean Potion Protect & Nourish Sport cooling SPF 50 8 fl oz (237 mL)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-217-24OP spf50 and Sport Sunscreen227 g in 1 CONTAINERLOTION2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-217OP SPF50 AND SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SOLSKYN PERSONAL CARE LLC]2Legacy NDC, 1 package rows20180213_596e542f-747e-43ba-9ce4-f5ab2d392e77.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-21770281-217-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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
a1fdec99-eba7-47a1-8357-fb7ae0cbc80d596e542f-747e-43ba-9ce4-f5ab2d392e772018-02-15WarningsExact identifier
spl id: a1fdec99-eba7-47a1-8357-fb7ae0cbc80d
spl set id: 596e542f-747e-43ba-9ce4-f5ab2d392e77

Reported adverse events (FAERS/openFDA)#

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