OLAY SENSITIVE SOOTHING MOISTURIZER SKIN PROTECTANT FRAGRANCE-FREE- colloidal oatmeal cream

Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free by

Drug Labeling and Warnings

Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, Cosmetic Essence, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

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

rashes eczema poison ivy, oak or sumac insect bites

Warnings

For external use only.

Do not get into eyes.

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

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

Directions

Apply as needed

INACTIVE INGREDIENT

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:

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)

OLAY

SENSITIVE

SENSITIVE

SOOTHING

MOISTURIZER

Colloidal Oatmeal

Skin Protectant

FRAGRANCE-FREE

Net Wt. 48 g (1.7 oz)

INGREDIENTS AND APPEARANCE

OLAY SENSITIVE SOOTHING MOISTURIZER SKIN PROTECTANT FRAGRANCE-FREE 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PALMITIC ACID (UNII: 2V16EO95H1)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONOL (50000 CST) (UNII: R2285D73YT)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOHEXADECANE (UNII: 918X1OUF1E)
SHEA BUTTER (UNII: K49155WL9Y)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
LAURETH-7 (UNII: Z95S6G8201)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PANTHENOL (UNII: WV9CM0O67Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-700-48	1 in 1 CARTRIDGE	03/06/2023
1		48 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 69423-700-15	1 in 1 CARTON	10/01/2023
2		15 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/06/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		825646862	manufacture(69423-700)