FDA.reportPublic FDA data

Olay Total Effects Moisturizer with Sunscreen

Product NDC
69423-388
11-digit product format
694230388
Labeler code
69423
Product ID
69423-388_3cbc46ef-dd26-3bf2-e063-6394a90a51df
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-10
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-38869423-388-15DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Total Effects Moisturizer with Sunscreen
Brand name suffix
Broad Spectrum SPF 15 Fragrance-Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE4 g/100mL
OCTISALATE4.5 g/100mL
OCTOCRYLENE2.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8de31db2-46cf-7178-e053-2995a90a5024Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-388-01Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free50 mL in 1 BOTTLE, PUMPLOTION506
69423-388-01Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free2 in 1 BLISTER PACKLOTION26
69423-388-10Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free1 in 1 CARTONLOTION16
69423-388-10Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free100 mL in 1 BOTTLE, PUMPLOTION1006
69423-388-11Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free100 mL in 1 BOTTLE, PUMPLOTION1006
69423-388-11Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free1 in 1 BLISTER PACKLOTION16
69423-388-15Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free1 in 1 CARTONLOTION16
69423-388-15Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free15 mL in 1 BOTTLE, PLASTICLOTION156
69423-388-50Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free1 in 1 CARTONLOTION16
69423-388-50Olay Total Effects Moisturizer with SunscreenBroad Spectrum SPF 15 Fragrance-Free50 mL in 1 BOTTLE, PUMPLOTION506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-388OLAY TOTAL EFFECTS MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 15 FRAGRANCE-FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 10 package rows20240927_8de31db2-46cf-7178-e053-2995a90a5024.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 107 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe686a22f-bddc-5d7c-e053-2995a90a7b282025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC090904d1-c04c-3fca-e063-6294a90a7cc72025-12-18WarningsExact identifier
application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral RichTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0a647c9a-2c71-4cd2-9503-e9ab96b857ee2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeepTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf246553e-17c2-4dba-855b-1942646bb8342025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep BronzeTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC15de58a4-e2bc-425b-b50b-df2d87dd3bb42025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf493c3ea-41b3-4625-84a6-fab545a769402025-12-18WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyd7238996-374b-07aa-e053-2995a90ae8892025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Companyeadacdae-3901-3f7c-e053-2a95a90ab1842025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyf6801575-6081-7566-e053-2995a90a20a82025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company00280745-908b-468f-e063-6294a90aa12f2025-12-18WarningsExact identifier
application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte FinishAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company10bd41ac-9b96-840d-e063-6394a90a98d92025-12-18WarningsExact identifier
application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company10bc4127-7569-d0de-e063-6294a90a97bf2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company29645d90-a444-4090-e063-6294a90ac7e32025-12-18WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Tan GoldenOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC46440bac-de69-e59c-e063-6394a90a76c02025-12-18WarningsExact identifier
application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming SunscreenZINC OXIDEDONG WHA PHARM. CO., LTD.46457c78-74d6-ea6a-e063-6294a90a24ac2025-12-18WarningsExact identifier
application number: M020
THE MUG GUARD Invisible Gel Suncare for FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4646988c-1060-ed5f-e063-6394a90aa7652025-12-18WarningsExact identifier
application number: M020
Sage and Zinc Facial Hydrating SPF15ZINC OXIDEEmeis Cosmetics Pty Ltdccabd647-ecdd-7230-e053-2a95a90a7a962025-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69423-388-01694230388012 BOTTLE, PUMP in 1 BLISTER PACK (69423-388-01) / 50 mL in 1 BOTTLE, PUMP2025-07-01NoNoCurrent
69423-388-10694230388101 BOTTLE, PUMP in 1 CARTON (69423-388-10) / 100 mL in 1 BOTTLE, PUMP2019-07-100000-00-00NoNoCurrent
69423-388-11694230388111 BOTTLE, PUMP in 1 BLISTER PACK (69423-388-11) / 100 mL in 1 BOTTLE, PUMP2024-01-10NoNoCurrent
69423-388-15694230388151 BOTTLE, PLASTIC in 1 CARTON (69423-388-15) > 15 mL in 1 BOTTLE, PLASTIC2019-07-100000-00-00NoNoCurrent
69423-388-50694230388501 BOTTLE, PUMP in 1 CARTON (69423-388-50) / 50 mL in 1 BOTTLE, PUMP2019-07-100000-00-00NoNoCurrent