Tender Moments Delicate Baby Bottom Balm

Tender Moments Delicate Baby Bottom Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

TENDER MOMENTS DELICATE BABY BOTTOM BALM- dimethicone, zinc oxide 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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Tender Moments Delicate Baby Bottom Balm

Active Ingredients Purpose

Dimethicone 2% Skin Protectant

Zinc Oxide 10% Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Helps Minor skin irritation due to diaper rash and helps protect from wetness

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

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Warnings

For external use only

When using this product, avoid contact with eyes

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 prolongued.

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

Jafra Tender Moments

Delicate Baby Bottom Balm

50 ml 1.7 FL OZ

TENDER MOMENTS DELICATE BABY BOTTOM BALM 
dimethicone, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-298
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 OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
OAT (UNII: Z6J799EAJK)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
PANTHENOL (UNII: WV9CM0O67Z)
WHITE WAX (UNII: 7G1J5DA97F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-298-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/15/2021	09/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/15/2021	09/15/2022

Labeler - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-298)

Revised: 9/2022

Document Id: e8cce259-13f1-7a8e-e053-2995a90aa3b2

34390-5

Set id: c6174455-4f37-e2e3-e053-2a95a90ae9c0

Version: 4

Effective Time: 20220916