FDA.reportPublic FDA data

Degil Sun SPF 30 Sunscreen

Product NDC
58331-060
11-digit product format
583310060
Labeler code
58331
Product ID
58331-060_16d8d1d0-e532-2a64-e063-6394a90a5b9c
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
OXYBENZONE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
2; 5; 2; 10.5; 2 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 30 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE2 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE2 g/100mL
HOMOSALATE10.5 g/100mL
OCTOCRYLENE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16d8d1d0-e531-2a64-e063-6394a90a5b9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
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
58331-060-01Degil Sun SPF 30 Sunscreen120 mL in 1 BOTTLELOTION1201
58331-060-02Degil Sun SPF 30 Sunscreen10 mL in 1 BOTTLELOTION101
58331-060-03Degil Sun SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
58331-060-04Degil Sun SPF 30 Sunscreen180 mL in 1 BOTTLELOTION1801
58331-060-05Degil Sun SPF 30 Sunscreen1000 mL in 1 BOTTLELOTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58331-060DEGIL SUN SPF 30 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC]1Current NDC, 5 package rows20240501_16d8d1d0-e531-2a64-e063-6394a90a5b9c.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 263 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
application number: M020
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
application number: M020
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d83c576-5dfb-583a-e063-6294a90a2a282024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d833e3b-5330-3c5b-e063-6394a90a2ed22024-12-09WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d9533ba-5606-4116-e063-6294a90ad3b12024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d82121d-1dc2-cd99-e063-6394a90aa7662024-12-09WarningsExact identifier
application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude310e66a2-8714-4016-87f4-81c1fef19ec92024-12-09WarningsExact identifier
application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitudeb6b8733d-6431-4ed2-9350-c63bb901c8042024-12-09WarningsExact identifier
application number: M020
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude06245c8c-93e8-4ebb-bab0-3db64dc178b92024-12-09WarningsExact identifier
application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc7b0d17-d7c8-433f-e053-2995a90a477d2024-12-09WarningsExact identifier
application number: M020
Sheer Zinc SPF 30ZINC OXIDEAllure Labsb6b45dac-41d0-1b55-e053-2a95a90acf612024-12-09WarningsExact identifier
application number: M020
Broad Spectrum SPF30 Mineral SunscreenZINC OXIDEAllure Labsdafc8e62-7c99-1f6d-e053-2995a90a77912024-12-09WarningsExact identifier
application number: M020
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58331-060-0158331006001120 mL in 1 BOTTLE (58331-060-01) 120 ml2024-05-01NoNoCurrent
58331-060-025833100600210 mL in 1 BOTTLE (58331-060-02) 10 ml2024-05-01NoNoCurrent
58331-060-035833100600330 mL in 1 BOTTLE (58331-060-03) 30 ml2024-05-01NoNoCurrent
58331-060-0458331006004180 mL in 1 BOTTLE (58331-060-04) 180 ml2024-05-01NoNoCurrent
58331-060-05583310060051000 mL in 1 BOTTLE (58331-060-05) 1000 ml2024-05-01NoNoCurrent