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#

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 29 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILIA SUPER SERUM SKIN TINT (ST12.5 RAMLA BAY)ZINC OXIDEIlia, Inc.b97f9d4d-6bdb-6823-e053-2995a90a51432026-05-21WarningsExact identifier
application number: M020
INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUMAVOBENZONE, HOMOSALATE, AND OCTISALATEInnisfree Corporation524264b8-d360-1d7b-e063-6394a90ab1152026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI)ZINC OXIDEIlia, Inc.b595bcc6-a1ab-25c9-e053-2995a90a87aa2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT)ZINC OXIDEIlia, Inc.b97f7fe9-c070-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE)ZINC OXIDEIlia, Inc.b959e3c3-ca92-ee41-e053-2a95a90a60642026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17 MIHO)ZINC OXIDEIlia, Inc.b595f875-b774-f847-e053-2995a90a28862026-05-21WarningsExact identifier
application number: M020
LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110COCTINOXATE, ZINC OXIDEBEL STAR S.A.526a8e50-b1de-47e5-e063-6394a90a3a292026-05-21WarningsExact identifier
application number: M020
Live Tinted Hueguard Skin TintZINC OXIDELive Tinted0ff39ab1-e8d3-cad9-e063-6394a90af0eb2026-05-21WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Quartz 001ZINC OXIDESunsolve MD Inc26a54f00-d84d-8fe3-e063-6394a90a03e82026-05-21WarningsExact identifier
application number: M020
Inde WildZINC OXIDEInde Wild01529c59-8806-6423-e063-6294a90a49e32026-05-21WarningsExact identifier
application number: M020
CARDON SPF and MOISTURIZERAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc52122434-6e6f-39fc-e063-6394a90a1fd02026-05-21WarningsExact identifier
application number: M020
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45OCTINOXATE AND ZINC OXIDEMerz North America, Inc62c822d9-c8ed-4b95-8d88-806295f5a9362026-05-20WarningsExact identifier
application number: M020
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
application number: M020
Stream2Sea SPF 50ZINC OXIDEStream2Sea5243f110-fe5b-946a-e063-6394a90add7e2026-05-20WarningsExact identifier
application number: M020
SP-FB0D-L0TNBarrierProtectionMineralSunscreenBARRIER PROTECTION MINERAL SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)50786950-1c31-e467-e063-6394a90a6fc82026-05-20WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
application number: M020
Evereden Cooling Mineral Sunstick SPF 30ZINC OXIDEEden Brands Inc.4af9e668-0d88-74ad-e063-6394a90a52432026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522addd5-9701-3234-e063-6294a90aaa9d2026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522b4aca-fe5b-dfe2-e063-6394a90ae5782026-05-19WarningsExact 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