Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER CREAM- babo botanicals sensitive baby fragrance free diaper cream cream 
Royal Labs Natural Cosmetics, Inc.

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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Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash

Protects chafed skin and minor irritation associated with diaper rash

Helps seal out wetness

Warnings

For external use only.

When using this product

Avoid contact with eyes

Stop use and ask doctor if

Conditions worsen

symptoms last more than seven days

symptoms 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 right away

Active Ingredient

Zinc Oxide 25% Purpose: Skin Protectant

Inactive Ingredients

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

Other Information

Protect this product from excessive heat and direct sun. You may report an adverse reaction to to the phone number or address provided below.

DIrections

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

Babo Botanicals Sensitive Baby Fragrance Free Diaper Cream

BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER CREAM 
babo botanicals sensitive baby fragrance free diaper cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69580-047
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69580-047-03	85 g in 1 TUBE; Type 0: Not a Combination Product	01/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/27/2021

Labeler - Royal Labs Natural Cosmetics, Inc. (197478480)

Registrant - Royal Labs Natural Cosmetics, Inc. (197478480)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics, Inc		197478480	manufacture(69580-047)

Revised: 1/2021

Document Id: b9e92425-0984-2fa5-e053-2a95a90ad60e

34390-5

Set id: b9e92425-0983-2fa5-e053-2a95a90ad60e

Version: 11

Effective Time: 20210127