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

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

Johnsons_01

JOHNSONS FIRST TOUCH BABY GIFT SET
zinc oxide kit

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:69968-0603-2	1 in 1 CARTON
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		400 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		05/28/2021

Part 3 of 3

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

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		400 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/15/2022

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

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Johnson’s® first touch baby gift set Desitin® Daily Defense Zinc Oxide Diaper Rash Cream