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

Aveeno Baby Essential Daily Care Baby and Mommy Gift Set by

Drug Labeling and Warnings

Aveeno Baby Essential Daily Care Baby and Mommy Gift Set by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Aveeno Baby® Soothing Relief Moisturizing Cream

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

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

Directions

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

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, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Steareth-20, Sodium Chloride, Benzyl Alcohol

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, Citric Acid

Questions?

Call toll-free 866-4 AVEENO or 215-273-8755 (collect) 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 immediately.

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 Carton

Aveeno
Baby®

essential daily care
baby & mommy gift set

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

FOR MOMMY
POSITIVELY RADIANT® daily moisturizer with sunscreen Broad Spectrum SPF 15,
4.0 fl oz (120mL) Daily Moisturizing Lotion, NET WT 2.5 oz (71g)

Pediatrician
Recommended®

PLUS FREE TOTE!
100% Natural Cotton Canvas

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0591

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0591-1	1 in 1 CONTAINER	02/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	141 g
Part 2	1 TUBE	227 mL
Part 3	1 TUBE	71 mL
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 RELIEF MOISTURIZING 
dimethicone cream

Product Information
Item Code (Source)	NDC: 69968-0437
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	12 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0437-5	141 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/22/2015

Part 2 of 6

AVEENO BABY DAILY MOISTURE 
dimethicone lotion

Product Information
Item Code (Source)	NDC: 69968-0441
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0441-8	227 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2001

Part 3 of 6

AVEENO DAILY MOISTURIZING 
dimethicone lotion

Product Information
Item Code (Source)	NDC: 69968-0454
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0454-4	71 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2004

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Titanium Dioxide (UNII: 15FIX9V2JP)
Mica (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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

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

Part 5 of 6

AVEENO BABY SOOTHING RELIEF CREAMY WASH 
baby shampoos lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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 Oleate (UNII: 4PC054V79P)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
INGR	POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	OATMEAL (UNII: 8PI54V663Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		12/04/2012

Part 6 of 6

AVEENO BABY LIGHTLY SCENTED WASH AND SHAMPOO 
baby shampoos solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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 Oleate (UNII: 4PC054V79P)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	OATMEAL (UNII: 8PI54V663Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		11/08/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)