FDA.reportPublic FDA data

Olay Total Effects Moisturizer with Sunscreen

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:11:10

Label at a glance#

ProductOlay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-Free
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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
Avobenzone 3.0%Sunscreen
Homosalate 4.0%Sunscreen
Octisalate 4.5%Sunscreen
Octocrylene 2.6%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

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • 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, glycerin, niacinamide, dimethicone, isopropylisostearate, panthenol, tocopheryl acetate, palmitoyl dipeptide-7, aloe barbadensis leaf juice powder, sodium ascorbyl phosphate, retinyl propionate, caprylyl glycol, dimethiconol, cetearyl alcohol, cetearyl glucoside, palmitic acid, stearic acid, behenyl alcohol, stearyl alcohol, cetyl alcohol, disodium EDTA, zea mays (corn) starch, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-100 stearate, titanium dioxide, 1,2-hexanediol, phenoxyethanol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Distr. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OLAY

TOTAL EFFECTS

7 IN

ONE

MOISTURIZER WITH sunscreen

BROAD SPECTRUM SPF 15
FRAGRANCE-FREE

50 mL (1.7 FL OZ)

OlayOlay

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

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-38869423-388-50, 69423-388-10, 69423-388-15, 69423-388-11, 69423-388-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
RETINYL PROPIONATE32JK994WMCIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PALMITIC ACID2V16EO95H1IACT
CETEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
BEHENYL ALCOHOL9G1OE216XYIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZEA MAYS (CORN) STARCHO8232NY3SJIACT
DIMETHICONOL (50000 CST)R2285D73YTIACT
ALOE BARBADENSIS LEAF POWDERZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PALMITOYL DIPEPTIDE-7JHF843U5C5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT

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 Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-FreeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company8de31db2-46cf-7178-e053-2995a90a50242025-08-19WarningsExact identifier
ndc (package): 69423-388-50
ndc (package): 69423-388-01
ndc (package): 69423-388-11
ndc (package): 69423-388-15
ndc (package): 69423-388-10
ndc (product): 69423-388
ndc11 (package): 69423038801
ndc11 (package): 69423038850
ndc11 (package): 69423038810
ndc11 (package): 69423038811
ndc11 (package): 69423038815
spl id: 3cbc46ef-dd26-3bf2-e063-6394a90a51df
spl set id: 8de31db2-46cf-7178-e053-2995a90a5024

Reported adverse events (FAERS/openFDA)#

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