FDA.reportPublic FDA data

Olay Complete UV365 Daily Moisturizer with Sunscreen

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:17

Label at a glance#

ProductOlay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Octisalate 2.5%Sunscreen
Octocrylene 2.5%Sunscreen
Zinc oxide 7.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, isohexadecane, glycerin, niacinamide, panthenol, camellia sinensis leaf extract, tocopheryl acetate, aloe barbadensis leaf extract, steareth-21, cyclopentasiloxane, polyacrylamide, stearyl alcohol, polymethylsilsesquioxane, polyethylene, C13-14 isoparaffin, behenyl alcohol, DMDM hydantoin, cetyl alcohol, triethoxycaprylylsilane, PEG/PPG-20/20 dimethicone, laureth-7, steareth-2, oleth-3 phosphate, disodium EDTA, iodopropynyl butylcarbamate.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OLAY ®

COMPLETE

30

UV365 Daily Moisturizer
with sunscreen

BROAD SPECTRUM SPF 30
SENSITIVE

75 mL (2.5 FL OZ) OlayOlay

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-258-752024-03-21C16284748780-1d6a99b39-d41f-a426-e053-dadaa90af4c2Olay ® Complete 30 UV365 Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive
69423-258-752022-01-28C16284748780-1d6a99b39-d41f-a426-e053-dadaa90af4c2Olay ® Complete 30 UV365 Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-258-75Olay Complete UV365 Daily Moisturizer with SunscreenBroad Spectrum SPF 30 Sensitive1 in 1 CARTONLOTION14
69423-258-75Olay Complete UV365 Daily Moisturizer with SunscreenBroad Spectrum SPF 30 Sensitive75 mL in 1 BOTTLE, PUMPLOTION754

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-25869423-258-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOHEXADECANE918X1OUF1EIACT
GLYCERINPDC6A3C0OXIACT
STEARETH-2153J3F32P58IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
NIACINAMIDE25X51I8RD4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DOCOSANOL9G1OE216XYIACT
DMDM HYDANTOINBYR0546TOWIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETYL ALCOHOL936JST6JCNIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PEG/PPG-20/20 DIMETHICONEBA94B7CK8KIACT
LAURETH-7Z95S6G8201IACT
STEARETH-2V56DFE46J5IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
EDETATE DISODIUM7FLD91C86KIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
C13-14 ISOPARAFFINE4F12ROE70IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
ndc (package): 69423-258-75
ndc (product): 69423-258
ndc11 (package): 69423025875
spl id: 463f88e6-0e7d-a2d7-e063-6294a90aec10
spl set id: 60a304b1-eee5-408b-e053-2a91aa0a0a08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.