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 283 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Mineral SunscreenZINC OXIDEWALGREEN COMPANYd50787f1-0c50-d153-e053-2995a90add1e2024-10-14WarningsExact identifier
application number: M020
Walgreens SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYcfd7c1b0-cfc3-074f-e053-2995a90a5edb2024-10-14WarningsExact identifier
application number: M020
Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWALGREEN COMPANYdfc64c7b-ee59-62a3-e053-2995a90a14a12024-10-14WarningsExact identifier
application number: M020
WALGREENS SPORT CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYe4b84304-6053-0cfe-e053-2a95a90a124a2024-10-14WarningsExact identifier
application number: M020
Walgreens 50 Baby Mineral SunscreenZINC OXIDEWALGREEN COMPANYdbee6094-e105-6d14-e053-2995a90a15282024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONcfd6dd4c-21f6-7cef-e053-2a95a90a50e22024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF50 Sport Sunscreen Lip Balm Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONf8c100bd-9230-813b-e053-6294a90ae0062024-10-14WarningsExact identifier
application number: M020
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
application number: M020
Target Goodfellow and Co SPF 30 Face Scent No. 05 Kelp and Sea MineralAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf98ee294-3ca5-18bd-e053-6394a90a9aa52024-10-14WarningsExact identifier
application number: M020
Target Up and Up Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf9027e42-017a-07fd-e053-6294a90ab9162024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
application number: M020
Up and Up Illuminating Daily Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATETARGET CORPORATION9407a4a9-8a72-6a01-e053-2a95a90a231d2024-10-14WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATIONf9b66e3e-5493-9ea4-e053-6294a90a60632024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a6296612-184c-6b3c-e053-2a95a90a34b92024-10-14WarningsExact identifier
application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6020d2f-55c4-adfc-e053-2a95a90ad2382024-10-14WarningsExact identifier
application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6044f0f-eb86-684d-e053-2995a90a09212024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a62848fb-7016-3457-e053-2a95a90aa0f12024-10-14WarningsExact identifier
application number: M020
Safeway Signature Care Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENESafeway, Inc.c6a0ae3e-d68a-b838-e053-2a95a90a77f72024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a628ff71-463d-4d39-e053-2995a90a7a422024-10-14WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONESafeway, Inc.c5106c63-af51-c169-e053-2a95a90afef22024-10-14WarningsExact 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