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 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf54c617f-794e-413b-b898-4a06622b4bee2026-03-24Warnings, Adverse reactionsExact identifier
application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporation7b2d15c1-b9e1-4347-b138-9883f78822b32026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen SPF30NON- NANO ZINC OXIDEDelta Ecommerce LLC2dda185c-6ff8-953d-e063-6394a90acc532026-03-24WarningsExact identifier
application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVEZINC OXIDETIRTIR USA Inc.4c92db00-59f1-ac02-e063-6394a90a7cf12026-03-23WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Soleil Group, LLC27d20573-0b6b-4d4b-94ca-69b476a883a72026-03-23WarningsExact identifier
application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.4db37efb-2d37-7428-e063-6394a90a10e42026-03-23WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen ButterZINC OXIDEElemental Herbs, Inc.ff334e9c-dd12-92bc-e053-6394a90aa24b2026-03-23WarningsExact identifier
application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50ZINC OXIDEElemental Herbs, Inc.fe2bf779-e8b3-933f-e053-6394a90a369f2026-03-23WarningsExact identifier
application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEskinnplus4dbc1035-c41c-308c-e063-6394a90a36c42026-03-23WarningsExact identifier
application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33ZINC OXIDEEva's Esthetics0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc72026-03-23WarningsExact identifier
application number: M020
MELAO Rice Probiotics SunscreenZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATEGuangdong Aimu Biological Technology Co., Ltd4ccaa734-83c1-611b-e063-6294a90ab3bf2026-03-21WarningsExact identifier
application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down CakeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.69022828-8226-4977-a2ca-ad8e16793a592026-03-20WarningsExact identifier
application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.c7794831-52d1-4d80-936d-44af18ae04722026-03-20WarningsExact identifier
application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral SunscreenZINC OXIDECA-Botana International4d74a36c-ff68-afd9-e063-6394a90a08f82026-03-20WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE468d4ed2-e616-aaaf-e063-6294a90af37a2026-03-20WarningsExact 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