CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE

Product NDC
58331-050
Requested package NDC
58331-050-03
11-digit product format
583310050
Labeler code
58331
Product ID
58331-050_ee029008-bcc8-4619-e053-2a95a90a399a
Type
HUMAN OTC DRUG
Nonproprietary name
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Degil Safety Products (1989) Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-02-18
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58331-05058331-050-03IInactivated by FDA2026-10-05

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58331-050-01CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE120 mL in 1 BOTTLE, PLASTICLOTION1205
58331-050-02CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE10 mL in 1 PACKETLOTION105
58331-050-03CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE750 mL in 1 BOTTLE, PLASTICLOTION7505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
HOMOSALATEACTIVE INGREDIENTV06SV4M95SCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
HOMOSALATEACTIVE MOIETYV06SV4M95SCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OCTISALATEACTIVE MOIETY4X49Y0596WCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ECROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
DIMETHICONE 1000INACTIVE INGREDIENTMCU2324216CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
POLYGLYCERYL-3 DISTEARATEINACTIVE INGREDIENTZI1LK470XVCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58331-050CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC.]5Legacy NDC, 3 package rows20221123_59999fef-259d-4077-8ebb-e884541973a0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58331-050-0358331005003750 mL in 1 BOTTLE, PLASTIC (58331-050-03) 750 ml2022-11-210000-00-00NoNoCurrent