AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET- dimethicone kit

Aveeno Baby Bathtime Solutions Baby and Mommy Gift Set by

Drug Labeling and Warnings

Aveeno Baby Bathtime Solutions Baby and Mommy Gift Set by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Container

Aveeno
Baby®
bathtime solutions
baby & mommy gift set

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

FOR MOMMY
Stress Relief Body Wash, 12 fl oz (354 mL)
Free Reusable Canvas Box

PEDIATRICIAN
Aveeno®
RECOMMENDED®

Naturally Nourishing Solutions for Precious Bathtime Moments

INGREDIENTS AND APPEARANCE

AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET 
dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0593

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0593-1	1 in 1 CONTAINER	06/16/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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
Item Code (Source)	NDC: 69968-0441
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
Sodium Chloride (UNII: 451W47IQ8X)
Allantoin (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0441-8	227 mL in 1 TUBE; Type 0: Not a Combination Product

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

Part 2 of 4

AVEENO BABY WASH AND SHAMPOO 
baby shampoos solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Sodium Lauroamphoacetate (UNII: SLK428451L)
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	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	OATMEAL (UNII: 8PI54V663Y)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		06/01/2010

Part 3 of 4

AVEENO BABY CALMING COMFORT BATH 
baby shampoos solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Sodium Lauroamphoacetate (UNII: SLK428451L)
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	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	OATMEAL (UNII: 8PI54V663Y)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		06/01/2010

Part 4 of 4

AVEENO STRESS RELIEF BODY WASH 
bath soaps and detergents lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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	GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Quaternium-15 (UNII: E40U03LEM0)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	Myristyl Alcohol (UNII: V42034O9PU)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		06/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/16/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)