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 firm2026-10-23

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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact 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