FDA.reportPublic FDA data

Aveeno Baby Essential Daily Care Baby and Mommy Gift Set

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-08-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:14:43

Label at a glance#

ProductAveeno Baby Essential Daily Care Baby and Mommy Gift Set
Active ingredientDimethicone, Avobenzone, Octinoxate, Octisalate
Label structure38 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Dosage and administration

Apply as needed.

Storage and handling

To open, twist off cap and remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Aveeno® Baby® Daily Moisture Lotion

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens.
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.

Other information

STORAGE AND HANDLING SECTION

  • To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Aveeno® Baby Soothing Relief Moisturizing Lotion

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns.

SAFETY TIP

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

Other information

STORAGE AND HANDLING SECTION

Remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Four, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Steareth-20, Sodium Chloride, Benzyl Alcohol

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Aveeno® Active Naturals® positively radiant daily moisturizer with sunscreen BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes.
  • rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soybean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glucoside, 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?

OTC - QUESTIONS SECTION

Call toll-free 1-866-4AVEENO(866-428-3366) or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

Aveeno® ACTIVE NATURALS® daily moisturizing lotion

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

STORAGE AND HANDLING SECTION

Store at Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-4AVEENO or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno
Baby®

essential daily care
baby & mommy gift set

FOR BABY:
• Wash & Shampoo, 8 fl Oz (236mL) • Daily Moisture Lotion, NET WT 8 oz (227g)
• Soothing Relief Creamy Wash, 8 fl Oz (236mL)• Soothing Relief Moisture Cream, NET WT 5 oz (141 g)

FOR MOMMY:
• POSITIVELY RADIANT® Daily Moisturizer with sunscreen Broad Spectrum SPF15,
4 fl. Oz. (120mL) • Daily Moisturizing Lotion, NET WT 2.5 oz (71g)

PLUS FREE TOTE!
100% Natural Cotton Canvas

PEDIATRICIAN
RECOMMENDED®

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 59 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-016569968-0165-9
69968-067969968-0679-8
69968-068069968-0680-4
69968-037169968-0371-4
69968-019869968-0198-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 91 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATZ6J799EAJKIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL OLEATE4PC054V79PINGR
SODIUM HYDROXIDE55X04QC32IINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
OATZ6J799EAJKINGR
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
GLYCERINPDC6A3C0OXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
GLYCERYL OLEATE4PC054V79PINGR
SODIUM BENZOATEOJ245FE5EUINGR
SUNFLOWER OIL3W1JG795YIINGR
SODIUM HYDROXIDE55X04QC32IINGR
OATZ6J799EAJKINGR
Dimethicone92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
ndc (package): 69968-0679-8
ndc11 (package): 69968067908
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
ndc (package): 69968-0679-8
ndc (product): 69968-0679
ndc11 (package): 69968067908
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
ndc (package): 69968-0680-4
ndc (product): 69968-0680
ndc11 (package): 69968068004
ef37d875-a4cb-4897-84f3-a61d71464fb2b78aba2a-d38f-4006-bf0e-c0213a5647802020-08-27WarningsExact identifier
spl id: ef37d875-a4cb-4897-84f3-a61d71464fb2
spl set id: b78aba2a-d38f-4006-bf0e-c0213a564780

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.