ZINC OXIDE spray, suspension

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Kindred Bravely, Royal Labs Natural Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxicd 25%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash
Helps seal out wetness

WARNINGS

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor

if symptoms last more than 7 days or clears 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.

Inactive Ingredients

Aqua (Water), Helianthus annuus (Sunflower) Oil, Simmondsia chinensis (Jojoba) Seed Oil, Ricinus communis (Castor) Seed Oil, Butyrospermum parkii (Shea) Butter, Cetearyl Alcohol, Cetearyl Glucoside, Organic Aloe barbadensis (Aloe vera) Leaf Juice, Glyceryl Caprylate, Caprylhydroxamic Acid, Xanthan Gum.

QUESTIONS

Distributed by Sensible

3913 Oceanic Drive, Suite 502

Oceanside, CA 92056

888-850-3756

www.kindredbravely.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide spray, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82751-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
WATER O-18 (UNII: 7QV8F8BYNJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82751-103-01	89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/14/2022

Labeler - Kindred Bravely (085227654)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Labs Natural Cosmetics		197478480	manufacture(82751-103)