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 54 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCaf052521-bfa6-4142-a10b-ef51f474a0772026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLC42647444-93a3-4d2c-9bfc-91621fd098f72026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCa4b9d7c0-dc09-4f0e-8b65-90ba180552bf2026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
application number: M020
Round Lab Birch Juice Mother s Day Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4cf03092-7886-ffa1-e063-6294a90a2aad2026-03-13WarningsExact identifier
application number: M020
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra lightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEL'Oreal USA, Inc.dad00eee-92cd-7610-e053-2a95a90a1fac2026-03-13WarningsExact identifier
application number: M020
VITARAN REJUVENA SUNCAREALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATEBR PHARM CO. , Ltd.4cb7af72-49f6-0738-e063-6394a90a79eb2026-03-12WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4cd0a8a7-11aa-e168-e063-6394a90a2ff22026-03-12WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEVi-Jon, LLC3da4706e-7c1a-435e-9603-e9aa984320182026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC53806657-7b4d-45ff-a75b-9340dcd8140e2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC08237b4c-4e5c-4b12-9510-2f8d64ab7f3a2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 FairfaxZINC OXIDETower 28108851ac-3812-4c02-a04a-9f9a7f529ed62026-03-12WarningsExact identifier
application number: M020
DIY Booster SPF 30 Facial Serum UnscentedOCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDEAndalou naturalsebaf5ef7-84aa-4cb1-a701-2e0d0fd357df2026-03-12WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation INC.f268fb1c-d7c2-f2f9-e053-2995a90a9e222026-03-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
application number: M020
CENTELLA SUNSCREEN CreamZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd4cbac4e9-7540-f703-e063-6394a90ad8082026-03-11WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-FreeZINC OXIDECOOLA LLC4cad89a5-325c-b3c2-e063-6294a90ac2252026-03-10WarningsExact identifier
application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 SensitiveAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4caf2ab5-76cb-4b0f-e063-6294a90a233e2026-03-10WarningsExact 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