JOHNSONS BABY CARE ESSENTIALS GIFT SET- zinc oxide kit

Johnsons Baby Care Essentials Gift Set by

Drug Labeling and Warnings

Johnsons Baby Care Essentials Gift Set by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DESITIN Maximum Strength Zinc Oxide Diaper Rash

Drug Facts

Active ingredient

Zinc Oxide (40%)

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

store at 20°C to 25°C (68°F to 77°F) may stain clothing

Inactive ingredients

Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance

Questions?

Call toll-free 800-720-3843 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - Kit Package

Johnson’s®

baby

baby care essentials

value

pack

all products are

TSA compliant!

Includes

JOHNSON’S® baby lotion 3.4 FL OZ (100 mL)

JOHNSON’S® HEAD-TO-TOE® wash & shampoo 3.4 FL OZ (100 mL)

DESITIN® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g).

A selection of gentle products to cleanse, moisturize, and care for baby’s delicate skin

INGREDIENTS AND APPEARANCE

JOHNSONS BABY CARE ESSENTIALS GIFT SET  
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0894

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0894-9	1 in 1 PACKAGE	08/02/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	28 g
Part 2	1 BOTTLE	100 mL
Part 3	1 BOTTLE	100 mL

Part 1 of 3

DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH 
zinc oxide paste

Product Information
Item Code (Source)	NDC: 69968-0848
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0848-9	1 in 1 CARTON
1		28 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 Drug	M016	05/14/2024

Part 2 of 3

JOHNSONS HEAD TO TOE WASH 
baby shampoos [baby products] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
INGR	PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 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		01/01/2024

Part 3 of 3

JOHNSONS BABY 
lotions, oils, powders, and creams [baby products] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	P-ANISIC ACID (UNII: 4SB6Y7DMM3)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 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		01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/02/2024

Labeler - Kenvue Brands LLC (118772437)