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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bright as Day Mineral SPF50ZINC OXIDEKoco Life LLC1c245a53-4098-62e6-e063-6294a90abf122024-09-23WarningsExact identifier
application number: M020
Pure Protect Mineral Sunscreen Stick SPF50ZINC OXIDEKoco Life LLC22cd5999-9b9a-91a3-e063-6394a90a0da52024-09-23WarningsExact identifier
application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.229dabbc-9043-3c9d-e063-6394a90a56922024-09-21WarningsExact identifier
application number: M020
GLC OG Natural Tinted SPF 30 SunscreenZINC OXIDEGUD LIFE CO. LLC25e1e8ec-e19d-45f7-b339-5d12c2b511d62024-09-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENETARGET CORPORATIONbad7d56e-662e-0776-e053-2a95a90a0af02024-09-18WarningsExact identifier
application number: M020
Target Up and Up Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb82b6d0d-616d-f041-e053-2995a90ae6a32024-09-18WarningsExact identifier
application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA LLC43d293f6-e13c-4ee9-89df-2a3ef0034e312024-09-16WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEAllure Labs22042031-ac8e-1ab2-e063-6394a90a6ed42024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEONESKIN INC.2204e776-b1a1-be15-e063-6294a90af5de2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEAllure Labs2205345b-5e92-37eb-e063-6294a90a6b6c2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf4130277-ea9b-6b25-e053-2a95a90a59be2024-09-13WarningsExact identifier
application number: M020
HEB SPF 50 Tattoo Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6df491d-1fa9-a4c8-e053-6394a90a38662024-09-13WarningsExact identifier
application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENESkin Ai, LLC21cbd5ac-5307-939b-e063-6294a90ac7912024-09-10WarningsExact identifier
application number: M020
Mario Badescu SPF 17AVOBENZONE, OCTINOXATE, OCTOCRYLENEBentley Laboratories LLC0fd51f8d-ee67-48fd-ab98-1fedb03394622024-09-10WarningsExact identifier
application number: M020
Mario Badescu Collagen SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC0246b11b-f1ba-4f47-91ab-52a6554b94672024-09-10WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLCf6d653f5-52a0-42ad-8308-b8d6f57050cc2024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBentley Laboratories LLCfe485d4c-0ded-4061-ac34-77b72d5350902024-09-10WarningsExact 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