TENDER MOMENTS DELICATE BABY DIAPER RASH BALM- dimethicone,zinc oxide cream

Tender Moments Delicate Baby Diaper Rash Balm by

Drug Labeling and Warnings

Tender Moments Delicate Baby Diaper Rash Balm by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Inc., Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 in a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

Other information

•  protect this product from excessive heat and direct sun

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

Questions?Call 1-800-551-2345 or visit www.jafra .com

Product label

INGREDIENTS AND APPEARANCE

TENDER MOMENTS DELICATE BABY DIAPER RASH BALM 
dimethicone,zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-700-01	1 in 1 CARTON	12/29/2021
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 Drug	M016	12/29/2021

Labeler - Distribuidora Comercial Jafra, S.A. de C.V. (951612777)

Registrant - Jafra Cosmetics International, Inc. (031183599)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-700)