FDA.reportPublic FDA data

Degil Sun SPF 50 Sunscreen

Product NDC
58331-075
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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
application number: M020
BEAST SPIT and POLISH FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC27e5244b-4b69-4dec-9dd5-ba8b71b171b22023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLCbd60cf89-e0e9-48ad-b174-1ecf72557d9c2023-11-11WarningsExact identifier
application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLC6d6b5b2a-210a-4606-9cdb-f6eec10f37e82023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Daily Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLC1745dc35-648e-4315-a285-c99ebeef4f6a2023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Face Factor Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCedc2c1e7-e1a8-4b49-96df-8a94eb6a242a2023-11-11WarningsExact identifier
application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF 50 SPORTOCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.f01516bf-8aed-4402-a3f9-ef11c54d46b32023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF-30OCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.4df55434-fb9a-442d-82cf-16a4957f0a2a2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-30ZINC OXIDEProject Reef LLCb7de9ec2-6db1-4c89-b734-15c4bd5c32512023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 SportHOMOSALATE, OCTISALATE, ZINC OXIDEThe Seaweed Bath Co.98ccbb70-6e1a-4e92-a095-cbc4be12fcbf2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEYouth Corridor5c0873ff-8e76-48de-919d-f69794c4bd372023-11-11WarningsExact identifier
application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
application number: M020
SUNNY Q Broad Spectrum SPF-30ZINC OXIDESunny Q Sunscreen LLC593870fa-425c-401c-ac26-f63f4ce0298f2023-11-11WarningsExact identifier
application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC44806b83-9220-4d34-806d-20cf0a47186e2023-11-11WarningsExact identifier
application number: M020
BRICKELL Element Defense Moisturizer SPF-45OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC94be278a-3773-469b-8e40-3242d1072a3d2023-11-11WarningsExact identifier
application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact 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
58331-075-0358331007503750 mL in 1 BOTTLE (58331-075-03) 750 ml2024-05-06NoNoCurrent