TENDER MOMENTS DELICATE BABY DIAPER RASH BALM- dimethicone,zinc oxide cream 
Jafra Cosmetics International, Inc.

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Tender Moments Delicate Baby Diaper Rash Balm

Active Ingredients

Dimethicone 2.0%, Zinc Oxide 10.0%

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 productdo 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 in 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 and 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

Inactive Ingredients

Water/Aqua, Petrolatum, Isopropyl Palmitate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexyl Stearate, Cetyl Dimethicone, Magnesium Sulfate, Beeswax/Cera Alba, Butyrospermum Parkii (Shea Butter), Panthenol, Butylene Glycol, Avena Sativa (Oat) Kernel Extract, DMDM Hydantoin, Glycine Soja (Soybean) Oil, Aloe Barbadensis Oil

Product label

image description
TENDER MOMENTS DELICATE BABY DIAPER RASH BALM 
dimethicone,zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
WHITE WAX (UNII: 7G1J5DA97F)  
SHEA BUTTER (UNII: K49155WL9Y)  
PANTHENOL (UNII: WV9CM0O67Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OAT (UNII: Z6J799EAJK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SOYBEAN OIL (UNII: 241ATL177A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-700-011 in 1 CARTON12/29/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01612/29/2021
Labeler - Jafra Cosmetics International, Inc. (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-700)

Revised: 12/2023
Document Id: 0daa74d4-147a-a7ea-e063-6394a90a84f4
Set id: f09ba452-e1a6-4f45-901f-bb63d4f8e884
Version: 4
Effective Time: 20231229
 
Jafra Cosmetics International, Inc.