JOHNSONS FIRST TOUCH BABY GIFT SET- zinc oxide kit

Johnsons First Touch Baby Gift Set by

Drug Labeling and Warnings

Johnsons First Touch Baby 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

Drug Facts

Active ingredient

Zinc Oxide 13%

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 cream 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)
• protect from freezing
• may stain clothing

Inactive ingredients

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Extract, Glycerin, Tropolone, Tocopheryl Acetate, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide, Phenoxyethanol.

Questions?

Call toll-free 800-720-3843 or 215-273-8755 (collect) or visit www.desitin.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Bag

Johnson’s ®

first touch

baby gift set

a selection of gentle products to cleanse, moisturize,

and care for baby’s delicate skin and hair

hypoallergenic, no parabens, phthalates, or dyes

Includes: JOHNSON’S ® head-to-toe ® wash & shampoo 13.6 FL OZ (400mL), JOHNSON’S ® baby lotion 13.6 FL OZ (400mL),

DESITIN ® daily defense zinc oxide diaper rash cream 2OZ (57 g), 1 recyclable storage caddy with handle

INGREDIENTS AND APPEARANCE

JOHNSONS FIRST TOUCH BABY GIFT SET 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0739

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0739-9	1 in 1 BAG	04/25/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	57 g
Part 2	1 BOTTLE	400 mL
Part 3	1 BOTTLE	400 mL

Part 1 of 3

DESITIN DAILY DEFENSE ZINC OXIDE DIAPER RASH 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 69968-0603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	130 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROPOLONE (UNII: 7L6DL16P1T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0603-2	1 in 1 CARTON
1		57 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	12/01/2018

Part 2 of 3

JOHNSONS HEAD TO TOE WASH AND 
baby shampoos [baby products] shampoo

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		400 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		05/28/2021

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	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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		400 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		07/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/25/2022

Labeler - Kenvue Brands LLC (118772437)