DailyMed - AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate kit

NDC Code(s): 69968-0371-4, 69968-0630-5, 69968-0679-8, 69968-0680-4, view more
69968-0698-9
Packager: Johnson & Johnson Consumer Inc.

Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION

Aveeno ® baby soothing hydration creamy oil

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, Avena Sativa (Oat) Kernel Oil, Steareth-20, Tocopheryl Acetate, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract.
Questions?

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

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
SPL UNCLASSIFIED SECTION

Aveeno DAILY MOISTURIZING lotion

Drug Facts
Active ingredient

Dimethicone (1.2%)
Purpose

Skin Protectant
Uses
- Helps prevent and temporarily protects chafed, chapped or cracked skin
- Helps prevent and protect from the drying effects of wind and cold weather
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

Store at Room Temperature
Inactive ingredients

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

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

Aveeno ® POSITIVELY RADIANT ® daily moisturizer sunscreen BROAD SPECTRUM SPF 15

Drug Facts
ACTIVE INGREDIENT

Active ingredient Purpose

Avobenzone 3% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 2 % Sunscreen
Use
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun
Warnings
- For external use only
- Do not use on damaged or broken skin
- When using this product keep out of eyes. Rinse with water to remove
- Stop use and ask a doctor if rash occurs
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
For sunscreen use:
- apply generously and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  - limit time in the sun, especially from 10 a.m. - 2 p.m.
  - wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
Other information
- protect this product from excessive heat and direct sun
- may stain some fabrics
Inactive ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soyabean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glycoside, Phenoxyethanol, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Polymethyl Methacrylate, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT, Sodium Hydroxide, Citric Acid, Titanium Dioxide, Mica
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 Package

RECOMMENDED BY

PEDIATRICIANS
& DERMATOLOGISTS

Aveeno ®

baby

essential

daily care

mommy & me

gift set

for BABY

Daily Moisture Wash & Shampoo 8 fl oz

(236 mL), Daily Moisture Lotion NET WT.

8 oz (227 g), Soothing Hydration Creamy

Wash 8 fl oz (236 mL), Soothing Hydration

Creamy Oil NET WT. 5 oz (141 g)

FOR MOM

Positively Radiant ® Daily Moisturizer

Broad Spectrum SPF 15 4 fl oz

(120 mL), Daily Moisturizing Lotion

NET WT. 2.5 oz (71 g)

Active ingredient	Purpose
Avobenzone 3%	Sunscreen
Octinoxate 7.5%	Sunscreen
Octisalate 2 %	Sunscreen

INGREDIENTS AND APPEARANCE

AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET
dimethicone, avobenzone, octinoxate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0698

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0698-9	1 in 1 PACKAGE	12/14/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	141 g
Part 2	1 TUBE	227 g
Part 3	1 TUBE	71 g
Part 4	1 BOTTLE, PUMP	120 mL
Part 5	1 BOTTLE	236 mL
Part 6	1 BOTTLE	236 mL

Part 1 of 6

AVEENO BABY SOOTHING HYDRATION CREAMY OIL
dimethicone cream

Product Information
Item Code (Source)	NDC:69968-0630
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)
OAT (UNII: Z6J799EAJK)
OAT KERNEL OIL (UNII: 3UVP41R77R)
SHEA BUTTER (UNII: K49155WL9Y)
STEARETH-20 (UNII: L0Q8IK9E08)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0630-5	141 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	06/01/2020

Part 2 of 6

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 final	part347	08/01/2001

Part 3 of 6

AVEENO DAILY MOISTURIZING
dimethicone lotion

Product Information
Item Code (Source)	NDC:69968-0680
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
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)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0680-4	71 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	06/01/2013

Part 4 of 6

AVEENO POSITIVELY RADIANT DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate lotion

Product Information
Item Code (Source)	NDC:69968-0371
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
SOYBEAN (UNII: L7HT8F1ZOD)
GLYCERIN (UNII: PDC6A3C0OX)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PANTHENOL (UNII: WV9CM0O67Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
DOCOSANOL (UNII: 9G1OE216XY)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LAURETH-7 (UNII: Z95S6G8201)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description
Packaging
1	NDC:69968-0371-4	1 in 1 CARTON
1		120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2015

Part 5 of 6

AVEENO BABY SOOTHING HYDARTION CREAMY WASH
baby shampoos lotion

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	GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
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		07/01/2020

Part 6 of 6

AVEENO BABY DAILY MOISTURE 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	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/14/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)

View All Sections

Published Date (What is this?)	Version	Files
Jan 9, 2023	6 (current)	download
Mar 23, 2022	5	download
Dec 14, 2021	4	download
Sep 3, 2021	3	download
Feb 11, 2021	2	download
Dec 15, 2020	1	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 ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate 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

When using this product

Stop use and ask a doctor if

Do not use on

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

	NDC
1	69968-0371-4
2	69968-0630-5
3	69968-0679-8
4	69968-0680-4
5	69968-0698-9

Label: AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate 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

When using this product

Stop use and ask a doctor if

Do not use on

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 ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate kit

Number of versions: 6

AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate kit

AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate kit

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate kit

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