FDA.reportPublic FDA data

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 169 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact identifier
application number: M020
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
application number: M020
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
application number: M020
Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd3ebe2a9-434e-497c-8fed-b5c73c70a58b2025-11-05WarningsExact identifier
application number: M020
Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.a57bcf44-580d-520e-e053-2a95a90a69232025-11-05WarningsExact identifier
application number: M020
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.865057ce-f617-4232-a60e-e23c120b0a732025-11-05WarningsExact identifier
application number: M020
Revitalize Solar Protection Fluid Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.29b3ee35-e849-4427-a455-37d92c4b995c2025-11-05WarningsExact identifier
application number: M020
Sarah Creal Brilliant Repair ShieldZINC OXIDESarah Creal LLC258ab6f2-f1a7-2d0d-e063-6294a90af34a2025-11-05WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
application number: M020
Sun Bum Face and Body Stick 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d9d60d-e0ce-a177-e063-6394a90a162e2025-11-05WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
application number: M020
SUNBEAT PROCARE FPS 50 KIDSHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLETecnoglobal, PH7 S.A. DE C.V.42c74ddf-70a3-f2b1-e063-6294a90a91a92025-11-04WarningsExact 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