BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH- zinc oxide spray

Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash by

Drug Labeling and Warnings

Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 14.9%

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 occurs again within a few days.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Shake well before use
• Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
• Spray 4-6 inches away from skin.
• Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
• No need to rub in.

Other information

• Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces.

Inactive ingredients

Water (Aqua), Olea Europaea (Olive) Fruit Oil, Propanediol, Ricinus Communis (Castor) Seed Oil, Bentonite, Glyceryl Rosinate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Olea Europaea (Olive) Oil Unsaponifiables, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Glyceryl Oleate.

*Certified Organic Ingredients

Questions or comments?

Call 1-800-422-2987 Mon-Fri 9:00AM - 5:00PM EST

Company Information

Dist by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	206 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERYL ROSINATE (UNII: SD112V492J)
BENTONITE (UNII: A3N5ZCN45C)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
GLYCERYL OLEATE (UNII: 4PC054V79P)
COCO GLUCOSIDE (UNII: ICS790225B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8576-1	89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/01/2022

Labeler - Babo Botanicals, Inc. (058258734)