FDA.reportPublic FDA data

Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:36

Label at a glance#

ProductOlay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

rashes eczema poison ivy, oak or sumac insect bites

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

Water, glycerin, isohexadecane, niacinamide, dimethicone, isopropyl isostearate, stearyl alcohol, cetyl alcohol, hydrogenated shea butter, panthenol, palmitoyl pentapeptide-4, ethylhexylglycerin, hydroxyacetophenone, dimethiconol, C13-14 isoparaffin, cetearyl Glucoside, cetearyl alcohol, laureth-7, stearic acid, palmitic acid, behenyl alcohol, disodium EDTA, polyacrylamide, PEG-100 stearate, phenoxyethanol

Questions:

OTC - QUESTIONS SECTION

1-800-285-5170

SPL UNCLASSIFIED SECTION

Manufactured in USA from local and

Imported Ingredients

Distr. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

www.olay.com

PRINCIPAL DISPLAY PANEL - 1.70 oz (48 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OLAY

SENSITIVE

SENSITIVE

SOOTHING

MOISTURIZER

Colloidal Oatmeal

Skin Protectant

FRAGRANCE-FREE

Net Wt. 48 g (1.7 oz)

OlayOlay

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN3
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD3
1654149colloidal oatmeal 0.5 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-700-15Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free1 in 1 CARTONCREAM13
69423-700-15Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free15 g in 1 JARCREAM153
69423-700-48Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free1 in 1 CARTRIDGECREAM13
69423-700-48Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free48 g in 1 JARCREAM483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-700OLAY SENSITIVE SOOTHING MOISTURIZER SKIN PROTECTANT FRAGRANCE-FREE (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 4 package rows20250306_026bb3a1-3e01-1530-e063-6294a90ab1b1.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-70069423-700-48, 69423-700-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
PALMITIC ACID2V16EO95H1IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONOL (50000 CST)R2285D73YTIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ISOHEXADECANE918X1OUF1EIACT
SHEA BUTTERK49155WL9YIACT
PALMITOYL PENTAPEPTIDE-4KK181SM5JGIACT
LAURETH-7Z95S6G8201IACT
NIACINAMIDE25X51I8RD4IACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
CETYL ALCOHOL936JST6JCNIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
WATER059QF0KO0RIACT
OATMEAL8PI54V663YACTIB
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PANTHENOLWV9CM0O67ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DOCOSANOL9G1OE216XYIACT
PEG-100 STEARATEYD01N1999RIACT

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 Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
ndc (package): 69423-700-48
ndc (package): 69423-700-15
ndc (product): 69423-700
ndc11 (package): 69423070048
ndc11 (package): 69423070015
spl id: 2f8a9574-dd22-121e-e063-6394a90a9b1e
spl set id: 026bb3a1-3e01-1530-e063-6294a90ab1b1

Reported adverse events (FAERS/openFDA)#

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