FDA.reportPublic FDA data

Olay Complete UV365 Daily Moisturizer Sensitive

Product NDC
69423-194
11-digit product format
694230194
Labeler code
69423
Product ID
69423-194_445cf184-8fb7-c421-e063-6294a90a1283
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-11
Substance
ZINC OXIDE; OCTINOXATE
Active strength
3; 6 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 packagepackage69423-19469423-194-50DDiscontinued by firm2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-19469423-194-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Complete UV365 Daily Moisturizer Sensitive
Brand name suffix
Broad Spectrum SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE3 g/100mL
OCTINOXATE6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5904baa8-3070-1d77-e053-2a91aa0a6852Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69423-194-012024-02-06Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-022024-02-06Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-122024-02-06Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-172024-02-06Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-502024-02-06Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-012024-01-30Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-022024-01-30Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-122024-01-30Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-172024-01-30Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15
69423-194-502024-01-30Olay ® Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-194-01Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 150.5 mL in 1 POUCHLOTION0.55
69423-194-02Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 152 in 1 BLISTER PACKLOTION25
69423-194-02Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 151 in 1 CARTONLOTION15
69423-194-12Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 151 in 1 CARTONLOTION15
69423-194-12Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 15120 mL in 1 BOTTLE, PLASTICLOTION1205
69423-194-17Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 151 in 1 CARTONLOTION15
69423-194-17Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 15177 mL in 1 BOTTLE, PLASTICLOTION1775
69423-194-50Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 1550 mL in 1 BOTTLE, PLASTICLOTION505
69423-194-50Olay Complete UV365 Daily Moisturizer SensitiveBroad Spectrum SPF 151 in 1 CARTONLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-194OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE BROAD SPECTRUM SPF 15 (OCTINOXATE AND ZINC OXIDE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC, 9 package rows20240207_5904baa8-3070-1d77-e053-2a91aa0a6852.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 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc596a4204-3d29-9023-e063-6294a90ad99e2026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Stream2Sea Ecostock SPF 40 SunscreenZINC OXIDEStream2Sea, LLC5866e026-a652-3300-e063-6394a90acff02026-08-06WarningsExact identifier
application number: M020
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-194-0169423019401.5 mL in 1 POUCH (69423-194-01) 2017-09-110000-00-00YesNoCurrent
69423-194-02694230194022 CARTON in 1 BLISTER PACK (69423-194-02) / 1 BOTTLE, PLASTIC in 1 CARTON / 177 mL in 1 BOTTLE, PLASTIC2 carton2020-02-030000-00-00NoNoCurrent
69423-194-12694230194121 BOTTLE, PLASTIC in 1 CARTON (69423-194-12) / 120 mL in 1 BOTTLE, PLASTIC2017-09-110000-00-00NoNoCurrent
69423-194-17694230194171 BOTTLE, PLASTIC in 1 CARTON (69423-194-17) / 177 mL in 1 BOTTLE, PLASTIC2017-09-110000-00-00NoNoCurrent
69423-194-50694230194501 BOTTLE, PLASTIC in 1 CARTON (69423-194-50) > 50 mL in 1 BOTTLE, PLASTIC2017-09-110000-00-00NoNoCurrent