Active ingredients

Manufacturer
ABBE Laboratories, Inc.
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:53:18

Label at a glance#

ProductPro-Tect Sports Sunscreen SPF 20
Active ingredientOCTINOXATE, MERADIMATE, OXYBENZONE, OCTISALATE
Label structure11 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 •children under 6 months: Ask a doctor • 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 p...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

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.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes.
Rinse with water to remove.

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 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
•children under 6 months: Ask a doctor
• 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 10a.m.–2 p.m.
•wear long-sleeved shirts, pants, hats, and sun-glasses

Other Information

OTHER SAFETY INFORMATION

•protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Questions or Comments

OTC - QUESTIONS SECTION

Dist. by ABBE Laboratories, Inc. • 1095 Route 110
Farmingdale, NY 11735 • 1-800-457-0990

RECENT MAJOR CHANGES SECTION


Uses 12/2020

Directions 12/2020

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A-CUTE DERM ®

medical skincare

PRO-TECT

SPF 20

SUNSCREEN

8.0 FL OZ (226.8 ml)

SPF 20 SUNSCREENSPF 20 SUNSCREEN

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68605-8640-2Pro-Tect Sports Sunscreen SPF 20907.2 g in 1 BOTTLE, PLASTICLOTION907.25
68605-8640-4Pro-Tect Sports Sunscreen SPF 20113.4 g in 1 BOTTLE, PLASTICLOTION113.45
68605-8640-8Pro-Tect Sports Sunscreen SPF 20226.8 g in 1 BOTTLE, PLASTICLOTION226.85

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68605-864068605-8640-4, 68605-8640-8, 68605-8640-2
37945-862

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-01-13monthly-update2026-06-03 17:52:44

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-Tect Sports Sunscreen SPF 20MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEABBE Laboratories, Inc.35869e8d-8e48-4b22-8af3-6964fe8ac1822026-04-09WarningsExact identifier
ndc (package): 68605-8640-4
ndc (package): 68605-8640-8
ndc (package): 68605-8640-2
ndc (product): 68605-8640
ndc11 (package): 68605864008
ndc11 (package): 68605864002
ndc11 (package): 68605864004
spl id: 5ad6f8f7-a816-4270-9d5b-f908b94a746c
spl set id: 35869e8d-8e48-4b22-8af3-6964fe8ac182
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact identifier
ndc (product): 37945-862
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
ndc (product): 37945-862

Reported adverse events (FAERS/openFDA)#

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