AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY 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® Daily Moisture Lotion

Drug Facts

Active ingredients

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, Allantoin, Sodium Chloride

Questions?

Call toll-free 866-4AVEENO or 215-273-8755 (collect) www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Label

FOR BABY	Aveeno
Wash & Shampoo, 8 fl oz (236 mL)	Baby®
Daily Moisture Lotion, 8 oz (227 g)
CALMING COMFORT® Bath, 8 fl oz (236 mL)

FOR MOMMY	bathtime solutions
Stress Relief Body Wash, 12 fl oz (354 mL) Free Reusable Canvas Box	baby & mommy gift set

PEDIATRICIAN RECOMMENDED®
Naturally Nourishing Solutions for Precious Bathtime Moments

AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0096

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0096-9	1 in 1 BOX	11/18/2015	12/11/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	227 mL
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
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 mL

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)
Oatmeal (UNII: 8PI54V663Y)
Benzyl Alcohol (UNII: LKG8494WBH)
Allantoin (UNII: 344S277G0Z)
Sodium Chloride (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		227 mL 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	12/01/2010

Part 2 of 4

AVEENO BABY WASH AND SHAMPOO
baby shampoos solution

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	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Glyceryl Oleate (UNII: 4PC054V79P)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
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		06/01/2010

Part 3 of 4

AVEENO BABY CALMING COMFORT BATH
baby shampoos solution

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	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Glyceryl Oleate (UNII: 4PC054V79P)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
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		06/01/2010

Part 4 of 4

AVEENO ACTIVE NATURALS STRESS RELIEF BODY WASH
bath soaps and detergents lotion

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	Edetate Sodium (UNII: MP1J8420LU)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Myristyl Alcohol (UNII: V42034O9PU)
INGR	Quaternium-15 (UNII: E40U03LEM0)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)

#	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		06/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	11/18/2015	12/11/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020

Document Id: 633e7d0a-7726-4ca2-bf68-d1eabb1f1bbf

Set id: 5154ca4d-f6f5-4967-a56b-182f9e767ee9

Version: 3

Effective Time: 20201001

Johnson & Johnson Consumer Inc.