Degil Sun SPF 50 Sunscreen

Product NDC
58331-075
Requested package NDC
58331-075-01
11-digit product format
583310075
Labeler code
58331
Product ID
58331-075_155aa0c5-6404-ee86-e063-6294a90a1c4d
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Degil Safety Products (1989) Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
5; 3; 4; 7; 13 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Degil Sun SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL
OXYBENZONE4 g/100mL
OCTOCRYLENE7 g/100mL
HOMOSALATE13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
95OOS7VE0YInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
155aa0c5-6403-ee86-e063-6294a90a1c4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58331-075-01Degil Sun SPF 50 Sunscreen120 mL in 1 BOTTLELOTION1201
58331-075-03Degil Sun SPF 50 Sunscreen750 mL in 1 BOTTLELOTION7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58331-075DEGIL SUN SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC]1Current NDC, 2 package rows20240501_155aa0c5-6403-ee86-e063-6294a90a1c4d.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 162 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
application number: M020
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
application number: M020
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
application number: M020
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
application number: M020
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
application number: M020
Baby Bare Republic Mineral SunscreenZINC OXIDECOOLA, LLCb292d1a9-7ff8-0faf-e053-2995a90ae3422025-11-14WarningsExact identifier
application number: M020
Aspen Islanders Sheer Mineral SportZINC OXIDEAspen Islanders LLC0fcb2adf-71c9-3369-e063-6294a90aa8062025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE MALON DAZEBy the Beach Suncare LLC4391728b-dfe7-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CITRUS CRUSHBy the Beach Suncare LLC43918d25-e947-5e17-e063-6394a90ada7c2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CANDY CLOUDSBy the Beach Suncare LLC4391728b-dfe8-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Balance and ClearZINC OXIDESunsolve MD Inc26f3595d-adef-a8a5-e063-6394a90adfd42025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Detox and ShieldZINC OXIDESunsolve MD Inc26f3886b-a3a5-c9b7-e063-6394a90af6c32025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Amber 002ZINC OXIDESunsolve MD Inc26e00001-9c68-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Agate 003ZINC OXIDESunsolve MD Inc26e00001-9c6f-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Bronzite 004ZINC OXIDESunsolve MD Inc26e13356-9ab5-246a-e063-6394a90a2a702025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Onyx 006ZINC OXIDESunsolve MD Inc26e16b5e-dd2e-6fb8-e063-6394a90a6a7f2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Calm and RevitalizeZINC OXIDESunsolve MD Inc26f3f534-a305-3530-e063-6394a90a75e12025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Garnet 005ZINC OXIDESunsolve MD Inc26e1508f-d386-329b-e063-6394a90a0a982025-11-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58331-075-0158331007501120 mL in 1 BOTTLE (58331-075-01) 120 ml2024-05-06NoNoCurrent