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

NDC Code(s): 69968-0441-8, 69968-0593-1, 69968-0679-8
Packager: Johnson & Johnson Consumer Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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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

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

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 5	1 TUBE	227 g

Part 1 of 5

AVEENO BABY DAILY MOISTURE
dimethicone lotion

Product Information
Item Code (Source)	NDC:69968-0441
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
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)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0441-8	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 Drug	M016	08/01/2001	06/30/2020

Part 2 of 5

AVEENO BABY WASH AND SHAMPOO
baby shampoos [baby products] solution

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)
INGR	WATER (UNII: 059QF0KO0R)

#	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 5

AVEENO BABY CALMING COMFORT BATH
baby shampoos [baby products] solution

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	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 5

AVEENO STRESS RELIEF BODY WASH
body and hand (excluding shaving preparations), rinse-off [skin care preparations (creams, lotions, powder, and sprays)] 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	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)

#	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

Part 5 of 5

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)
OATMEAL (UNII: 8PI54V663Y)
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 Drug	M016	08/01/2001

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/16/2019

Labeler - Johnson & Johnson Consumer Inc. (118772437)

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Published Date (What is this?)	Version	Files
Feb 9, 2024	6 (current)	download
Jan 9, 2023	5	download
Mar 23, 2022	4	download
Jul 21, 2020	3	download
Jun 17, 2019	2	download

	RxCUI	RxNorm NAME	RxTTY
1	876980	dimethicone 1.2 % Topical Lotion	PSN
2	876980	dimethicone 12 MG/ML Topical Lotion	SCD
3	876980	dimethicone 1.2 % Topical Lotion	SY

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

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Drug Label Information

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Stop use and ask a doctor if

Do not use on

Find additional resources

Safety

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More Info on this Drug

	NDC
1	69968-0441-8
2	69968-0593-1
3	69968-0679-8

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

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

When using this product

Stop use and ask a doctor if

Do not use on

Find additional resources

Safety

Related Resources

More Info on this Drug

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

Number of versions: 5

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

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

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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.