FDA.reportPublic FDA data

Pro-Tect Sports Sunscreen SPF 20

Product NDC
68605-8640
11-digit product format
686058640
Labeler code
68605
Product ID
68605-8640_5ad6f8f7-a816-4270-9d5b-f908b94a746c
Type
HUMAN OTC DRUG
Nonproprietary name
Meradimate, Octinoxate, Octisalate, Oxybenzone
Dosage form
LOTION
Route
CUTANEOUS
Labeler
ABBE Laboratories, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active strength
75; 50; 30; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68605-8640-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68605-8640-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68605-8640-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68605-8640-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68605-8640-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68605-8640-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68605-8640-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68605-8640-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68605-8640-40efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pro-Tect Sports Sunscreen SPF 20
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
MERADIMATE50 mg/g
OXYBENZONE30 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
J9QGD60OUZInternal UNII lookup
95OOS7VE0YInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35869e8d-8e48-4b22-8af3-6964fe8ac182Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68605-8640-22025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-22025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-42025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-42025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-82025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-82025-02-1235869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-22025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-22025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-42025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-42025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-82025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182
68605-8640-82025-01-3035869e8d-8e48-4b22-8af3-6964fe8ac182

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68605-8640PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [ABBE LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20250213_35869e8d-8e48-4b22-8af3-6964fe8ac182.zip

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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDICUBE PDRN SILKY SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC57154bec-6714-0314-e063-6294a90a4bd02026-07-20WarningsExact identifier
application number: M020
TOCOBO Double UV Defense SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON Co., Ltd.56aff65a-aa08-dc3f-e063-6294a90acac32026-07-19WarningsExact identifier
application number: M020
THE SPORTO Invisible Sport for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.46564a09-909d-bcc7-e063-6294a90a627b2026-07-17WarningsExact identifier
application number: M020
RR Sun CremeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Incdc60b685-a7fc-47bb-ade9-44a8e3b548122026-07-17WarningsExact identifier
application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.0ef2ebae-7198-47f4-8891-d1ca3cf54d4b2026-07-16WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
application number: M020
BaseLife Pure Mineral Shield SunscreenZINC OXIDEWintech America, Inc.7f741a91-6ed8-4d08-9196-d15527d044d52026-07-15WarningsExact identifier
application number: M020
BaseLife Clear UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWintech America, Inc.128db446-93ba-4347-bd39-66177572c6592026-07-15WarningsExact identifier
application number: M020
Biore Aqua Rich Facial Mist SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKao USA Inc.56a80a0d-b0b5-1098-e063-6294a90a52702026-07-15WarningsExact identifier
application number: M020
Anti Aging Lip Balm Pot SPF 15LIP BALMEpicuren Disocovery4097e28a-ed11-e16a-e063-6294a90a5e9b2026-07-14WarningsExact identifier
application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50ZINC OXIDECALM ENTERPRISE LLC722462d8-d2ab-44ce-9065-673ab20762692026-07-14WarningsExact identifier
application number: M020
X-Treme Cream Propolis Sunscreen SPF 45X-TREME CREAMEpicuren Discovery3b29976e-eee0-b978-e063-6294a90accd62026-07-14WarningsExact identifier
application number: M020
Anti-Aging Lip Balm SPF 15LIP BALMEpicuren Discovery3cbd0550-b6e5-3e86-e063-6394a90ac07f2026-07-14WarningsExact identifier
application number: M020
Zinc Oxide Perfecting SunscreenZINC OXIDEEpicuren Discovery1a0228f9-bf3f-a1fe-e063-6294a90a3fb52026-07-14WarningsExact identifier
application number: M020
Vacation FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.14b8a3cf-031c-4c52-ba81-e683e69d0f372026-07-14WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEL. Perrigo Companybd5c9df7-8dfb-4d20-9966-e148c5667b222026-07-14WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC4081a4ad-b738-5fb6-e063-6394a90a91712026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc5c1d8-91f8-8ad2-e063-6294a90a92292026-07-13WarningsExact identifier
application number: M020
Olay Super Serum Body Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company5513c5e2-3baf-2f09-e063-6394a90a495a2026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc48592-f70d-664e-e063-6294a90ac6e82026-07-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68605-8640-268605864002907.2 g in 1 BOTTLE, PLASTIC (68605-8640-2) 907.2 g2022-05-010000-00-00NoNoCurrent
68605-8640-468605864004113.4 g in 1 BOTTLE, PLASTIC (68605-8640-4) 113.4 g2022-05-010000-00-00NoNoCurrent
68605-8640-868605864008226.8 g in 1 BOTTLE, PLASTIC (68605-8640-8) 226.8 g2022-05-010000-00-00NoNoCurrent