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 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef FriendlyAVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONETHE KROGER COMPANYc706aaf0-a978-7848-e053-2995a90a0aca2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCc51029f4-ede0-08ef-e053-2995a90aecaf2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE,TOPCO ASSOCIATES LLCc8af028e-9d68-4023-e053-2995a90ad18a2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc5601d22-2353-7319-e053-2a95a90a16c02024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc8c12a5a-59f5-6515-e053-2995a90a58f72024-10-15WarningsExact identifier
application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc6268778-8dcc-24b6-e053-2995a90acf032024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf0de2999-f12b-89b1-e053-2a95a90ac6102024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50ZINC OXIDETOPCO ASSOCIATES LLCd501a94e-3bcd-d8e4-e053-2a95a90a33b02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Kids Mineral SunscreenZINC OXIDETOPCO ASSOCIATES LLCdbee42c8-9cae-7a81-e053-2a95a90a23292024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf12c09b1-8ffe-4933-e053-2995a90a434f2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30ZINC OXIDETOPCO ASSOCIATES LLCdbf03882-ab1a-9805-e053-2995a90a71092024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCf31ea60e-1f52-c55f-e053-2a95a90afe642024-10-15WarningsExact identifier
application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact 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