FDA.reportPublic FDA data

Olay Regenerist Micro-Sculpting Hydrating Moisturizer

Product NDC
84126-034
Requested package NDC
84126-034-50
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 136 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d9c77-ed9f-a518-e063-6394a90a34fa2025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374e2294-7281-c7b9-e063-6394a90acc892025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
application number: M020
Non - Tinted Mineral SunscreenZINC OXIDENEXTEX CORPORATION35bacfcf-0254-aa0a-e063-6394a90a14752025-12-11Exact identifier
application number: M020
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
application number: M020
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
application number: M020
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
application number: M020
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
application number: M020
flawless photo finishZINC OXIDENEXTEX CORPORATION35bb0ac4-6abd-ca75-e063-6394a90a26cd2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
application number: M020
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
application number: M020
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incroporated352fe5e4-8b3f-248f-e063-6394a90ab42c2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incorporated3530898c-7bdf-6ffe-e063-6394a90aa0372025-12-11Exact identifier
application number: M020

Packages#

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