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 309 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf296e5ef-728a-4d57-8d65-7d88b1f90f882023-12-31WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide MineralTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incbcf5e724-b40a-49dd-8a09-57cefd7f65ad2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Correct Broad Spectrum SPF 70 Daily SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca7c01228-02db-49a8-bb91-cee13fbd1df12023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc202d8dda-b425-498f-aa82-1470c0cf0c232023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Ince72ae48f-e4ec-458b-ae2b-bd6cb98552f92023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc197ea8bf-0d84-42cb-bf29-087ad95878772023-12-31WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 SunscreenHOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENEL'Oreal USA Products, Inc.2138f86b-3937-4c2b-9568-d40a745b637d2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XLAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc533e6623-108e-4d05-8527-c5af643f08002023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense 24 Hour Hydrating Moisturizer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production2f90f046-080b-4033-97b0-245fcc0f36832023-12-31WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEL'Oreal USA Products Inc27d82e37-67ac-4cd3-83c0-fb8388d3a0dd2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Incd7bf3928-85b8-4e5f-a04a-d520130a33402023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Incdc1a1b9f-fcc1-45bc-89e7-169bf240663d2023-12-31WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8e94e203-d3cf-45a1-88f9-6999f0aab22b2023-12-31WarningsExact identifier
application number: M020
Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing TreatmentAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc30cb2f12-1ebe-4850-be16-17748f0ba6702023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc74ea4031-bb23-4028-ae32-78213646f66c2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdd6134f8-e2e0-49bf-bfec-ab04bfa5678b2023-12-30WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3d9ed59f-f280-4cc2-a0f1-4180deb5b7922023-12-30WarningsExact identifier
application number: M020
IT Cosmetics Your Skin But Better CC Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum SPF 40 Sunscreen All ShadesHOMOSALATE, OCTISALATE AND OCTOCRYLENEIT COSMETICS, LLC2bdc6c73-d3e7-4a23-89dd-e4ffe44c034b2023-12-30WarningsExact identifier
application number: M020
Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc02c51b56-e39a-4b3b-88c6-b7dc9c165f7e2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact 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