FDA.reportPublic FDA data

Pur Confort SPF 15

Product NDC
54181-015
11-digit product format
541810015
Labeler code
54181
Product ID
54181-015_5b1cf88b-582f-b5a0-e063-6294a90abd47
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Guinot
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
Marketing end
2027-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
28.5; 50; 70; 30; 90 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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
Pur Confort SPF 15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE28.5 mg/mL
HOMOSALATE50 mg/mL
OCTINOXATE70 mg/mL
OCTISALATE30 mg/mL
OCTOCRYLENE90 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fe0656f-f924-48da-91bf-d6f3d98e8fd9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54181-015-50Pur Confort SPF 1550 mL in 1 JARCREAM504
54181-015-50Pur Confort SPF 151 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54181-015PUR CONFORT SPF 15 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) CREAM [GUINOT]3Current NDC, Legacy NDC, 2 package rows20231020_2fe0656f-f924-48da-91bf-d6f3d98e8fd9.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 186 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e66c234-a152-098e-e063-6394a90ab5402025-09-10WarningsExact identifier
application number: M020
Basin Sun Stick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3e78026e-0a6a-9e67-e063-6294a90a1bca2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 30N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.428dac83-37dc-4b54-82e9-664f59f9af332025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 31N Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3174b962-12c0-43b4-8a9c-56fb044afd662025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 34W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c4135505-f0c5-4a91-91e2-ca0e38a0136c2025-09-10WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 35W DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.c5f65d27-4ad8-4188-98aa-0d9c2dd361802025-09-10WarningsExact identifier
application number: M020
Zinc Oxide Titanium OxideZINC OXIDE TITANIUM OXIDEHello Bello3e89d30e-b6cd-fabe-e063-6294a90a30ff2025-09-10WarningsExact identifier
application number: M020
Ocean Potion Suncare 30 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60bd44-1984-57c6-e063-6294a90a1f4e2025-09-09WarningsExact identifier
application number: M020
Ocean Potion Suncare 70 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e60d362-4700-1042-e063-6394a90ab39f2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 25W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.3d2a702b-2ff6-473a-9ab1-823e0e53a8cf2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 29W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.285c9b63-ae65-4508-8bba-1541b3cc43802025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 26C Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.733fbb38-1481-415c-8161-18816e87ee4b2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 28W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.42d51bd5-0678-4e30-80f7-db10281b95282025-09-09WarningsExact identifier
application number: M020
Sunglaze Body Gel Cream Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC3e6658a1-ae6a-9d19-e063-6294a90acae72025-09-09WarningsExact identifier
application number: M020
CLARINS Extra Firming Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins57f07e8a-1043-47e4-9d7b-6e78fdc341192025-09-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC1d3218e6-8687-4a94-8bf7-3a867920cd1c2025-09-08WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC6c578ef8-5648-4428-b9a2-0952f96252532025-09-08WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC16ac7877-8dfd-3d69-e063-6394a90a5a8a2025-09-08WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD388fb3db-29d2-bb29-e063-6394a90a4efb2025-09-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54181-015-50541810015501 JAR in 1 BOX (54181-015-50) / 50 mL in 1 JAR1 jar2018-05-012027-02-01NoNoCurrent