BABO SENSITIVE BABY ALL NATURAL HEALING- skin protectant ointment

Babo Sensitive Baby All Natural Healing by

Drug Labeling and Warnings

Babo Sensitive Baby All Natural Healing by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Colloidal Oatmeal 1% Skin protectant

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to rashes eczema poison ivy and insect bites.

Warnings

For external use only.When using this product Do not get into eyes Stop use and ask a doctor if Conditions worsens symptoms last more than 7 days or clear up and occur again within a few days. - In case of accidental ingestion, contact a physician or a Poison Control Center immediately.

When using this product

When using this product Do not get into eyes

Stop use and ask a doctor if

Stop use and ask a doctor if Conditions worsens symptoms last more than 7 days or clear up and occur again within a few days. - In case of accidental ingestion, contact a physician or a Poison Control Center immediately.

Directions

Apply as needed. Children under 3 months: ask a doctor.

Keep out of reach of children

Keep out of reach of children.

Inactive Ingredients

Beeswax*, Bisabolol*, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Extract*, Eucalyptus Globulus Leaf Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Nasturtium Officinale (Watercress) Flower/leaf Extract*, Olea Europaea (Olive) Fruit Oil*, Pueraria Lobata (Kudzu) Root Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Rosmarinus Officinalis (Rosemary) Leaf Oil*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*.

*Certified Organic Ingredient

Distributed by

Dist: by Babo Botanicals, Inc.

60 East 56th Street

New York, NY 10022

Information Panel

This waterless ointment provides head to toe relief for itchy skin and minor skin irritations, such as eczema and insect bites.

Packed with pure goodness and vitamin rich oils that protect and lock in moisture.

gluten, soy & dairy free

paraben & phthalate free

dermatologist tested

preservative free

steroid free

mineral oil free

PEDIATRICIAN TESTED

DERMATOLOGIST TESTED

HYPOALLERGENIC

79265-8565 Principal Display Panel

79265-8565-0 113 g Outer Packaging Box

79265-8765 Principal Display Panel

79265-8765-0 Principal Display Panel

INGREDIENTS AND APPEARANCE

BABO SENSITIVE BABY ALL NATURAL HEALING 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8765
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)	0.1 mL  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	10 mL  in 100 g
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)	0.0015 mL  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.0015 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	0.01 mL  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	0.01 mL  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.25 mL  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.0015 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	25 mL  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.0015 mL  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	63.2725 mL  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.06 mL  in 100 g
TEA TREE OIL (UNII: VIF565UC2G)	0.05 mL  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)	0.1 mL  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.0015 mL  in 100 g
ROSEMARY (UNII: IJ67X351P9)	0.04 mL  in 100 g
ROSEMARY OIL (UNII: 8LGU7VM393)	0.1 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8765-0	1 in 1 BOX	11/01/2020
1	NDC: 79265-8765-1	113 g in 1 JAR; 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	11/01/2020	10/23/2023

BABO SENSITIVE BABY ALL NATURAL HEALING 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8565
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.0015 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	0.01 mL  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	0.01 mL  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.25 mL  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.0015 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	25 mL  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.0015 mL  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	63.2725 mL  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.06 mL  in 100 g
TEA TREE OIL (UNII: VIF565UC2G)	0.05 mL  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)	0.1 mL  in 100 g
ROSEMARY OIL (UNII: 8LGU7VM393)	0.1 mL  in 100 g
ROSEMARY (UNII: IJ67X351P9)	0.04 mL  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	10 mL  in 100 g
LEVOMENOL (UNII: 24WE03BX2T)	0.1 mL  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.0015 mL  in 100 g
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)	0.0015 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8565-0	1 in 1 BOX	11/01/2020
1	NDC: 79265-8565-1	113 g in 1 JAR; 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	11/01/2020	07/31/2024

Labeler - Babo Botanicals, Inc. (058258734)