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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF 30 Sun StickBROAD SPECTRUM SPF 30 SUN STICKRaining Rose, Inca35a7973-443b-5247-e053-2a95a90a44592023-10-23WarningsExact identifier
application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip BalmCRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c3aa41-c9a0-4f64-e053-2995a90a005e2023-10-23WarningsExact identifier
application number: M020
Super Mint SPF 15 Broad Spectrum Lip BalmSUPER MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9626a2f-9931-78d2-e053-2995a90ac40f2023-10-23WarningsExact identifier
application number: M020
Spearmint SPF 30 Broad Spectrum Lip BalmSPEARMINT SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b520dc-bae6-614f-e053-2995a90ae6772023-10-23WarningsExact identifier
application number: M020
Citrus SPF 15 Broad Spectrum Lip BalmCITRUS SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d0651-6001-29ce-e053-2a95a90a967f2023-10-23WarningsExact identifier
application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip BalmCOCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0d2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Vanilla SPF 30 Broad Spectrum Lip BalmVANILLA SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0c2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip BalmPINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7c6684f-1122-20c1-e053-2995a90ae6cf2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
application number: M020
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip BalmCARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a42f6-27d1-e2cc-e053-2a95a90aa6da2023-10-23WarningsExact identifier
application number: M020
Iced Pear SPF 15 Broad Spectrum Lip BalmICED PEAR SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c4a0ec-e07e-1cda-e053-2a95a90a0f3f2023-10-23WarningsExact identifier
application number: M020
Lemonade SPF 15 Broad Spectrum Lip BalmLEMONADE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8ffc32b-b758-0f8f-e053-2995a90adb622023-10-23WarningsExact identifier
application number: M020
Strawberry SPF 15 Broad Spectrum Lip BalmSTRAWBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902d590-0726-ad6f-e053-2995a90a11302023-10-23WarningsExact identifier
application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip BalmORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9005cb1-ae1a-7736-e053-2995a90a28ea2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLCf2f3601f-081a-4bae-e053-2a95a90a4fac2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLC82f48635-1dc4-8c0d-e053-2991aa0a60cc2023-10-23WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1TITANIUM DIOXIDEAmway Corp7494fe09-40e0-4152-9974-a6e8a4d7f4212023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1TITANIUM DIOXIDEAmway Corpcec51b88-a6b8-4b64-b3aa-830e712a3c8a2023-10-22WarningsExact 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