JOHNSONS BATH DISCOVERY BABY GIFT SET- zinc oxide kit

Johnsons Bath Discovery baby Gift Set by

Drug Labeling and Warnings

Johnsons Bath Discovery 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

Desitin® Rapid Relief zinc oxide diaper rash cream

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 Container

Johnson's®

bath

discovery™

baby gift set

descubramos el baño set de regalo para bebĕ

more than

getting clean,

it's time to

play and learn

Your Gift Contains: JOHNSON'S® safety swabs 55 CT JOHNSON'S® baby shampoo 7 FL OZ (207 mL) JOHNSON'S® HEAD-TO-TOE® baby lotion 9 FL OZ (266 mL) JOHNSON'S® HEAD-TO-TOE® baby wash 9 FL OZ (266 mL) JOHNSON'S® baby powder soothing aloe & vitamin e 9 OZ (255 g) DESITIN® Rapid Relief zinc oxide diaper rash cream 2 OZ (57 g) JOHNSON'S® baby bubble bath 3 FL OZ (89 mL)Safety Swabs 55 CT 1 Bath Caddy

INGREDIENTS AND APPEARANCE

JOHNSONS BATH DISCOVERY BABY GIFT SET 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0354

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0354-1	1 in 1 CONTAINER	07/07/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	57 g
Part 2	1 BOTTLE	266 mL
Part 3	1 BOTTLE	207 mL
Part 4	1 BOTTLE	266 mL
Part 5	1 BOTTLE	89 mL
Part 6	1 BOTTLE	255 g

Part 1 of 6

DESITIN RAPID RELIEF DIAPER RASH 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 69968-0219
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
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
Dimethicone (UNII: 92RU3N3Y1O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
Microcrystalline Wax (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
Tropolone (UNII: 7L6DL16P1T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-Hexanediol (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
Potassium Hydroxide (UNII: WZH3C48M4T)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0219-2	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 FINAL	part347	10/20/2015

Part 2 of 6

JOHNSONS HEAD-TO-TOE BABY 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Starch, Corn (UNII: O8232NY3SJ)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
INGR	Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
INGR	Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
INGR	Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	P-Anisic Acid (UNII: 4SB6Y7DMM3)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		266 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		06/15/2012

Part 3 of 6

JOHNSONS BABY 
baby shampoos shampoo

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Sodium Trideceth Sulfate (UNII: E827ILX331)
INGR	PEG-150 Distearate (UNII: 6F36Q0I0AC)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
INGR	D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		207 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		06/15/2011

Part 4 of 6

JOHNSONS BABY HEAD-TO-TOE WASH 
bath soaps and detergents 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	Sodium Trideceth Sulfate (UNII: E827ILX331)
INGR	PEG-150 Distearate (UNII: 6F36Q0I0AC)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		266 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		06/15/2012

Part 5 of 6

JOHNSONS BABY BUBBLE WASH 
bath soaps and detergents 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	Sodium Trideceth Sulfate (UNII: E827ILX331)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Laureth-4 (UNII: 6HQ855798J)
INGR	Sodium Lauroamphoacetate (UNII: SLK428451L)
INGR	Disodium Lauroamphodiacetate (UNII: R4HKX6I64R)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		89 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		06/15/2012

Part 6 of 6

JOHNSONS BABY   SOOTHING ALOE AND VITAMIN E
powders (dusting and talcum, excluding aftershave talc) powder

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	STARCH, CORN (UNII: O8232NY3SJ)
INGR	Tricalcium Phosphate (UNII: K4C08XP666)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		255 g 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		06/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/07/2016

Labeler - Johnson & Johnson Consumer Inc. (002347102)