Label: 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
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 consumer or patient please visit this version.

  • 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 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

  • 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)

    Principal Display Panel - Kit Package
  • INGREDIENTS AND APPEARANCE
    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 PACKAGE12/14/2020
    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 finalpart34712/14/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)