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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%
Available from:
Johnson & Johnson Consumer Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - Helps prevent and temporarily protects chafed, chapped, or cracked skin. Skin Protectant - Helps prevent and temporarily protects chafed, chapped or cracked skin Sunscreen - 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. Skin Protectant - Helps prevent and temporarily protects chafed, chapped, or cracked skin - Helps prevent and protect from the drying effects of wind and cold weather
Authorization status:
OTC monograph final
Authorization number:
69968-0165-9, 69968-0198-5, 69968-0371-4, 69968-0679-8, 69968-0680-4

AVEENO BABY ESSENTIAL DAILY CARE BABY AND MOMMY 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.

----------

Aveeno Baby

Essential Daily Care Baby and Mommy Gift Set

Aveeno

Baby

Daily Moisture Lotion

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpos e

Skin Protectant

Us es

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, Allantoin, Sodium Chloride

Ques tions ?

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

Aveeno

Baby Soothing Relief Moisturizing Lotion

Drug Facts

Active ingredient

Dimethicone 1.25%

Purpos e

Skin Protectant

Us e

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 Four, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil,

Butyrospermum Parkii (Shea) Butter, Steareth-20, Sodium Chloride, Benzyl Alcohol

Ques tions ?

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

Aveeno

Active Naturals

positively radiant daily moisturizer with sunscreen BROAD SPECTRUM

SPF 15

Drug Facts

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Purpos e

Sunscreen

Us es

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

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 (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

Ques tions ?

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

Aveeno

ACTIVE NATURALS daily moisturizing lotion

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpos e

Skin Protectant

Us es

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

Ques tions ?

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

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 (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

®

AVEENO BABY ESSENTIAL DAILY CARE BABY AND MOMMY GIFT SET

dimethicone, avobenzone, octinoxate, and octisalate kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 16 5

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 16 5-9

1 in 1 CARTON

0 2/0 1/20 16

0 4/21/20 21

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

227 g

Pa rt 2

1 BOTTLE

236 mL

Pa rt 3

1 BOTTLE

236 mL

Pa rt 4

1 TUBE

71 g

Pa rt 5

1 BOTTLE, PUMP

120 mL

Pa rt 6

1 TUBE

141 g

Part 1 of 6

AVEENO BABY DAILY MOISTURE

dimethicone lotion

Product Information

Ite m Code (Source )

NDC:6 9 9 6 8 -0 6 79

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (Dimethico ne - UNII:9 2RU3N3Y1O)

Dime thic o ne

12 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

O AT (UNII: Z6 J79 9 EAJK)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

ALLANTO IN (UNII: 344S277G0 Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 6 79 -8

227 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 8 /0 1/20 0 1

Part 2 of 6

AVEENO BABY WASH AND SHAMPOO

baby shampoos solution

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

WATER (UNII: 0 59 QF0 KO0 R)

INGR

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

INGR

SO DIUM LAURO AMPHO ACETATE (UNII: SLK428 451L)

INGR

GLYCERIN (UNII: PDC6 A3C0 OX)

INGR

CO CO GLUCO SIDE (UNII: ICS79 0 225B)

INGR

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

INGR

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

INGR

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

INGR

GLYCERYL O LEATE (UNII: 4PC0 54V79 P)

INGR

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

INGR

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

INGR

O AT (UNII: Z6 J79 9 EAJK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

236 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

12/0 4/20 12

Part 3 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: 0 59 QF0 KO0 R)

INGR

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

INGR

GLYCERIN (UNII: PDC6 A3C0 OX)

INGR

SO DIUM LAURO AMPHO ACETATE (UNII: SLK428 451L)

INGR

CO CO GLUCO SIDE (UNII: ICS79 0 225B)

INGR

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

INGR

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

INGR

GLYCERYL O LEATE (UNII: 4PC0 54V79 P)

INGR

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

INGR

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

INGR

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

INGR

O AT (UNII: Z6 J79 9 EAJK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

236 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

12/0 4/20 12

Part 4 of 6

AVEENO DAILY MOISTURIZING

dimethicone lotion

Product Information

Ite m Code (Source )

NDC:6 9 9 6 8 -0 6 8 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (Dimethico ne - UNII:9 2RU3N3Y1O)

Dime thic o ne

12 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

O AT (UNII: Z6 J79 9 EAJK)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 9 6 8 -0 6 8 0 -4

71 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 2/0 1/20 0 4

Part 5 of 6

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