AVEENO BABY BATHTIME SOLUTIONS BABY AND ME GIFT SET- dimethicone
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aveeno® baby bathtime solutions baby and me gift set AVEENO® Baby Daily Moisture Lotion

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

For external use only.

When using this product

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

Do not use on

Deep or puncture wounds
Animal bites
Serious burns

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

Directions

Apply as needed.

Other information

To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
Store at room temperature.

Inactive ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

Questions?

866-428-3366; Outside US dial collect 215-273-8755 www.aveeno.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Container

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

bathtime

solutions

baby and me

gift set

Includes: Daily Moisture Wash & Shampoo 8 fl oz

(236 mL), Daily Moisture Lotion 8 oz (227 g),

CALMING COMFORT® Bath 8 fl oz (236mL) and

Stress Relief Body Wash 12 fl oz (354 mL)

aveeno

AVEENO BABY BATHTIME SOLUTIONS BABY AND ME GIFT SET
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0756

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0756-9	1 in 1 CONTAINER	06/01/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	227 g
Part 2	1 BOTTLE	236 mL
Part 3	1 BOTTLE	236 mL
Part 4	1 BOTTLE	354 mL

Part 1 of 4

AVEENO BABY DAILY MOISTURE
dimethicone lotion

Product Information
Item Code (Source)	NDC:69968-0679
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OAT (UNII: Z6J799EAJK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0679-8	227 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/2001

Part 2 of 4

AVEENO BABY DAILY MOISTURE WASH AND SHAMPOO
baby shampoos liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	GLYCERYL OLEATE (UNII: 4PC054V79P)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
INGR	OAT (UNII: Z6J799EAJK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/06/2020

Part 3 of 4

AVEENO BABY CALMING COMFORT BATH
baby shampoos liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	GLYCERYL OLEATE (UNII: 4PC054V79P)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	OAT (UNII: Z6J799EAJK)
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCO GLUCOSIDE (UNII: ICS790225B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/01/2020

Part 4 of 4

AVEENO STRESS RELIEF BODY WASH
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	MYRISTYL ALCOHOL (UNII: V42034O9PU)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		354 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2022

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 1/2023

Document Id: ef3bb20e-53d9-8908-e053-2a95a90af605

Set id: dceca111-5dae-557b-e053-2995a90a3fa0

Version: 2

Effective Time: 20230106

Johnson & Johnson Consumer Inc.