FDA.reportPublic FDA data

Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day

Product NDC
49967-952
11-digit product format
499670952
Labeler code
49967
Product ID
49967-952_5be14dac-571c-478c-8c3f-464b544977cb
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate and Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-01
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
20; 50; 80 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE20 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal 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
08645f1d-7ba7-4410-8600-3d3f79d71385Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-952-01Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day50 g in 1 JARCREAM5012
49967-952-01Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day1 in 1 CARTONCREAM112
49967-952-02Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day1 in 1 CARTONCREAM112
49967-952-02Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day75 g in 1 JARCREAM7512
49967-952-03Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day15 g in 1 JARCREAM1512
49967-952-03Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day1 in 1 CARTONCREAM112
49967-952-04Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day2 g in 1 PACKETCREAM212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4
OctisalateACTIVE INGREDIENT4X49Y0596WLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4
OctocryleneACTIVE INGREDIENT5A68WGF6WMLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4
AvobenzoneACTIVE MOIETYG63QQF2NOXLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4
OctisalateACTIVE MOIETY4X49Y0596WLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4
OctocryleneACTIVE MOIETY5A68WGF6WMLANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-952LANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]12Current NDC, Legacy NDC, 7 package rows20231224_08645f1d-7ba7-4410-8600-3d3f79d71385.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 183 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN2ZINC OXIDEPUR Minerals3f06ed2f-f43f-53d4-e063-6294a90af0dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN4ZINC OXIDEPUR Minerals3f06f618-f7b2-53d0-e063-6294a90a829c2025-09-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-952-01499670952011 JAR in 1 CARTON (49967-952-01) / 50 g in 1 JAR1 jar2010-06-010000-00-00NoNoCurrent
49967-952-02499670952021 JAR in 1 CARTON (49967-952-02) / 75 g in 1 JAR1 jar2010-06-010000-00-00NoNoCurrent
49967-952-03499670952031 JAR in 1 CARTON (49967-952-03) / 15 g in 1 JAR1 jar2010-06-010000-00-00NoNoCurrent
49967-952-04499670952042 g in 1 PACKET (49967-952-04) 2 g2010-06-010000-00-00NoNoCurrent