FDA.reportPublic FDA data

Olay Regenerist Micro-Sculpting Hydrating Moisturizer

Product NDC
84126-034
11-digit product format
841260034
Labeler code
84126
Product ID
84126-034_463e41d1-ec7b-4cb8-e063-6394a90aac3d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Substance
OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Active strength
4.5; 6; 3; 9 g/100mL; g/100mL; g/100mL; g/100mL
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
Olay Regenerist Micro-Sculpting Hydrating Moisturizer
Brand name suffix
Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100mL
OCTOCRYLENE6 g/100mL
AVOBENZONE3 g/100mL
HOMOSALATE9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal 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
248be719-edff-f40d-e063-6394a90a4ef6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-034-15Olay Regenerist Micro-Sculpting Hydrating MoisturizerBroad Spectrum SPF 301 in 1 CARTONCREAM12
84126-034-15Olay Regenerist Micro-Sculpting Hydrating MoisturizerBroad Spectrum SPF 3015 mL in 1 TUBECREAM152
84126-034-50Olay Regenerist Micro-Sculpting Hydrating MoisturizerBroad Spectrum SPF 3050 mL in 1 BOTTLE, PUMPCREAM502
84126-034-50Olay Regenerist Micro-Sculpting Hydrating MoisturizerBroad Spectrum SPF 301 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-034OLAY REGENERIST MICRO-SCULPTING HYDRATING MOISTURIZER BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 4 package rows20241027_248be719-edff-f40d-e063-6394a90a4ef6.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 311 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca32f7458-d7ad-47e5-804d-de260c0726de2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc9b6adfab-cafa-4343-9c96-e187fe0986db2023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURSTZINC OXIDE SUNSCREENBentley Laboratories, LLC4785585e-b623-4125-9867-8097694c7b582023-12-29WarningsExact identifier
application number: M020
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8e294a61-97e2-4df8-8a59-7cec12c6f0162023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30- SUNSET ROSEZINC OXIDE SUNSCREENBentley Laboratories, LLCe351dff2-4237-4458-a947-b894e7b670a32023-12-29WarningsExact identifier
application number: M020
LOreal Paris Wrinkle Expert Age Defense 55 Plus Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incfa0b25a9-648a-4c7e-95c0-b7cb3dd525dd2023-12-29WarningsExact identifier
application number: M020
Radiant Shield Broad spectrum SPF 40 Tinted Mineral SunscreenZINC OXIDECosMedical Technologies, LLCef75cd9d-eaf5-430e-9a80-30c50da921ff2023-12-28WarningsExact identifier
application number: M020
SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc76e03a17-947a-492a-9e64-d3f7762de8232023-12-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Hydra Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inccc61299b-5088-4cef-b90e-f5de67e46b252023-12-28WarningsExact identifier
application number: M020
Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incea0609be-eaa9-4b63-9f07-e2cd974e01ba2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incb3a37055-b58f-4c42-963b-01c1136f692d2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Inc52e169b7-3560-489e-b7ab-1fea01466c0c2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Matte Plus Poreless Mattifying Poreless Primer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incc0c2aac2-1cd3-4e97-894c-a828fd9dba9b2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 SunscreenOCTINOXATELOreal USA Products Incfeabb713-4ef1-45b3-b34f-562e37b314d52023-12-28WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.dc3f8339-23c1-4882-8682-685623027bdf2023-12-27WarningsExact identifier
application number: M020
Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incaec1957a-f68d-4fbd-af9e-f8b257daea462023-12-27WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc8404ef40-35fd-4460-a35f-d473b3c04c872023-12-27WarningsExact identifier
application number: M020
Dermablend Professional CC Continuous Correction Full Coverage Makeup Broad Spectrum SPF 50 Plus SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc4514240-f09b-48e3-94d6-d45dc426900e2023-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-034-15841260034151 TUBE in 1 CARTON (84126-034-15) / 15 mL in 1 TUBE1 tube2024-04-01NoNoCurrent
84126-034-50841260034501 BOTTLE, PUMP in 1 CARTON (84126-034-50) / 50 mL in 1 BOTTLE, PUMP2024-04-01NoNoCurrent