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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.22821e9d-eb3a-4e21-87ae-737b251255342024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Shimmer SunscreenZINC OXIDEMeadow and Bark14bbd191-ef3b-628e-e063-6294a90a1e662024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Sport SunscreenZINC OXIDEMeadow and Bark1494c0e1-97f5-411c-e063-6294a90ab2ca2024-04-03WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBEL STAR S Aea3a0e07-a277-48c8-e053-2a95a90a172f2024-04-02WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodySprayOCTOCRYLENE, OCTISALATE, AVOBENZONESol de Janeiro USA, Inc1520a151-70c4-8699-e063-6294a90adc6b2024-04-02WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer075efd92-1632-d8c8-e063-6294a90a8c1a2024-04-02WarningsExact identifier
application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30ZINC OXIDEGood Molecules, LLCe9596344-a7ab-f582-e053-2a95a90a55252024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum MinisHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.f5c4186e-f167-40fc-b308-0b4406d3ec552024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HolidayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.95d9a485-7418-437a-8e7d-ebcc090883562024-04-02WarningsExact identifier
application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30ZINC OXIDEAllure Labs14cff1a3-89b9-f4da-e063-6394a90a1a412024-03-29WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral SunscreenZINC OXIDELemongrass Spa Products, LLC14bcbaf9-76a5-f8ba-e063-6294a90a91f62024-03-28WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarefree Skincare Ventures, LLC14bd5cf9-423e-53a8-e063-6394a90a29f12024-03-28WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50ZINC OXIDEALLI LLC25a88843-078b-4589-b8b7-ea439ba6a15b2024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodyLotionZINC OXIDESOL DE JANEIRO USA, INC.14a85a88-c9a2-94ea-e063-6394a90a4e142024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 Body OilOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESOL DE JANEIRO USA, INC.14acf152-e72a-debb-e063-6294a90a243d2024-03-27WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
application number: M020
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
application number: M020
Eminence Daily Defense Tinted SPFZINC OXIDEEminence Organic Skin Care14854bad-317e-154d-e063-6294a90a884f2024-03-25WarningsExact identifier
application number: M020
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact 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