TENDER MOMENTS BABY BOTTOM BALM- zinc oxide, dimethicone cream

Tender Moments by

Drug Labeling and Warnings

Tender Moments by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Zinc Oxide/CI77947, Dimethicone

Soothing balm for baby's tender bottom that helps treat and prevent diaper rash.

No Such information

If condition worsens or does not improve within 7 days, consult a doctor.

For external use only. Avoid contact with eyes

To use: With each diaper change, cleanse the diaper area and and allow to dry. Apply baby bottom balm liberally, especially when exposure to wet diapers may be prolonged.

Other ingredients: Water/aqua, petrolatum, Diisostearoyl Polyglyceryl-3 Diisostearate, Ethylhexyl stearate, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Oil, Butyrospermum Parkii (Shea Butter) Fruit, Panthenol, Glycine Soja (Soybean) Oil. Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butylene Glycol, DMDM Hydantoin, PEG-4 Laurate, Iodopropynyl Butylcarbamate.

PRINCIPAL DISPLAY PANEL

Tender Moments

Baby Bottom Balm

Crema Suavizante para Rozaduras

Jafra 

 50 ml 1.7 fl. oz

INGREDIENTS AND APPEARANCE

TENDER MOMENTS  BABY BOTTOM BALM
zinc oxide, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OAT (UNII: Z6J799EAJK)
PANTHENOL (UNII: WV9CM0O67Z)
SOYBEAN OIL (UNII: 241ATL177A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
WHITE WAX (UNII: 7G1J5DA97F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-095-01	1 in 1 BOX	06/07/2012
1		50 mL 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 not final	part352	06/07/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-095)