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 2 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020
SPF30 Sunscreen 01AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5b04751d-32e9-a7e2-e063-6294a90aefbd2026-09-08WarningsExact identifier
application number: M020
Juyasuyon Invisible SunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd5ab335b5-bb9e-4642-e063-6294a90a39862026-09-05WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEBCMC41cc2c52-c6a4-611c-e063-6294a90aae012026-09-03WarningsExact identifier
application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALMART, INC.58b5d0ce-9157-9dee-e063-6394a90ab5432026-09-02WarningsExact identifier
application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Inc6186ea56-7d56-43f5-985d-a012f1296afa2026-09-02WarningsExact identifier
application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact identifier
application number: M020
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact 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