Aveeno Calm Plus Restore Skin Therapy Balm

Manufacturer: Kenvue Brands LLC
Effective date: 2025-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:03:00

Label at a glance#

ProductAveeno Calm Plus Restore Skin Therapy Balm

Active ingredientOATMEAL

Label structure11 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.

Storage and handling

Do not use if quality seal is broken or missing. Store at Room Temperature

Contacts and useful links#

PhoneLabel contact866-428-3366

PhoneLabel contact215-273-8755

Websitewww.aveeno.com

www.aveeno.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

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

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

Other information

STORAGE AND HANDLING SECTION

Do not use if quality seal is broken or missing.
Store at Room Temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US, dial collect 215-273-8755

www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 48g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Aveeno _®

Calm +

Restore

SKIN THERAPY BALM

Colloidal Oatmeal Skin Protectant

Sensitive Skin

Soothes and deeply

moisturizes to help

strengthen skin’s

natural moisture barrier

STEROID FREE

FRAGRANCE-FREE

DERMATOLOGIST RECOMMENDED BRAND

COLLOIDAL OATMEAL + CERAMIDE

net wt. 1.7 oz (48 g)

Aveeno_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240651	colloidal oatmeal 1 % Topical Cream	PSN	5
240651	colloidal oatmeal 10 MG/ML Topical Cream	SCD	5
240651	Avena sativa 1 % Topical Cream	SY	5
240651	colloidal oatmeal 1 % Topical Cream	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0755-2	Aveeno Calm Plus Restore Skin Therapy Balm	1 in 1 CARTON	CREAM	1		5
69968-0755-2	Aveeno Calm Plus Restore Skin Therapy Balm	48 g in 1 TUBE	CREAM	48		5

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Aveeno Calm Plus Restore Skin Therapy Balm
Colloidal Oatmeal
BENZALKONIUM CHLORIDE
OATMEAL
SODIUM CHLORIDE
PANTHENOL
ISOPROPYL PALMITATE
STEARETH-20
OAT KERNEL OIL
CERAMIDE NP
MEDIUM-CHAIN TRIGLYCERIDES
OAT
WATER
GLYCERIN
DISTEARYLDIMONIUM CHLORIDE
DISTEARYLDIMONIUM
PETROLATUM
CETYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69968-0755	69968-0755-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
OATMEAL	8PI54V663Y	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
PANTHENOL	WV9CM0O67Z	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
STEARETH-20	L0Q8IK9E08	IACT
OAT KERNEL OIL	3UVP41R77R	IACT
CERAMIDE NP	4370DF050B	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
OAT	Z6J799EAJK	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
DISTEARYLDIMONIUM CHLORIDE	OM9573ZX3X	IACT
PETROLATUM	4T6H12BN9U	IACT
CETYL ALCOHOL	936JST6JCN	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aveeno Calm Plus Restore Skin Therapy Balm	COLLOIDAL OATMEAL	Kenvue Brands LLC	dbe7a2cc-9c21-2a48-e053-2a95a90a54e2	2025-06-04	Warnings	Exact identifier ndc (package): 69968-0755-2 ndc (product): 69968-0755 ndc11 (package): 69968075502 spl id: 36bdeede-e154-67e7-e063-6294a90ac506 spl set id: dbe7a2cc-9c21-2a48-e053-2a95a90a54e2

Reported adverse events (FAERS/openFDA)#

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