Label: JOHNSONS FIRST TOUCH BABY GIFT SET- zinc oxide kit
- NDC Code(s): 69968-0603-2, 69968-0739-9
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2023
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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
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INGREDIENTS AND APPEARANCE
JOHNSONS FIRST TOUCH BABY GIFT SET
zinc oxide kitProduct 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 creamProduct 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 final part347 12/01/2018 Part 2 of 3 JOHNSONS HEAD TO TOE WASH AND
baby shampoos shampooProduct 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 lotionProduct 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 final part347 04/25/2022 Labeler - Johnson & Johnson Consumer Inc. (118772437)