Tender moments Baby Bottom Balm

TENDER MOMENTS BABY BOTTOM BALM- zinc oxide, dimethicone cream
JAFRA COSMETICS INTERNATIONAL

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.

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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.

Tender Moments

Baby Bottom Balm

Crema Suavizante para Rozaduras

Jafra

50 ml 1.7 fl. oz

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/07/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

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