AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET- dimethicone, avobenzone, octinoxate, and octisalate 
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 Essential Daily Care Mommy and Me Gift Set

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

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

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

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

Drug Facts

Active ingredientPurpose
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

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)

Principal Display Panel - Kit Package
AVEENO BABY ESSENTIAL DAILY CARE MOMMY AND ME GIFT SET 
dimethicone, avobenzone, octinoxate, and octisalate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0698
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0698-91 in 1 PACKAGE12/14/202005/04/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 141 g
Part 21 TUBE 227 g
Part 31 TUBE 71 g
Part 41 BOTTLE, PUMP 120 mL
Part 51 BOTTLE 236 mL
Part 61 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0630-5141 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2020
Part 2 of 6
AVEENO BABY DAILY MOISTURE 
dimethicone lotion
Product Information
Item Code (Source)NDC:69968-0679
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0679-8227 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2001
Part 3 of 6
AVEENO DAILY MOISTURIZING 
dimethicone lotion
Product Information
Item Code (Source)NDC:69968-0680
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0680-471 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2013
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0371-41 in 1 CARTON
1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2015
Part 5 of 6
AVEENO BABY SOOTHING HYDARTION CREAMY WASH 
baby shampoos lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGROATMEAL (UNII: 8PI54V663Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/01/2020
Part 6 of 6
AVEENO BABY DAILY MOISTURE WASH AND SHAMPOO 
baby shampoos solution
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRGUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
INGROAT (UNII: Z6J799EAJK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/14/202005/04/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
 
Johnson & Johnson Consumer Inc.