Drug Facts

Active ingredient

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash
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 within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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.
May stain some fabrics and surfaces.

Inactive ingredients

BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT*, COCOS NUCIFERA (COCONUT) OIL*, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LECITHIN, NASTURTIUM OFFICINALE (WATERCRESS) LEAF EXTRACT*, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT*, SPIRAEA ULMARIA (MEADOWSWEET) EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*

*Certified Organic Ingredients

Questions or comments?

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

Product Packaging

BABO FRAGRANCE FREE DIAPER CREAM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79265-8566
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.001 g in 100 g
CANDELILLA WAX (UNII: WL0328HX19)	5 g in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.001 g in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	5 g in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.001 g in 100 g
ROSEMARY (UNII: IJ67X351P9)	0.25 g in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	0.75 g in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.001 g in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	43.744 g in 100 g
CORN OIL (UNII: 8470G57WFM)	10 g in 100 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	0.25 g in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)	10 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.002 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79265-8566-3	85 g in 1 TUBE; Type 0: Not a Combination Product	08/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	08/26/2020

Labeler - Babo Botanicals, Inc. (058258734)

Babo Fragrance Free Diaper Cream