Drug Facts

Active Ingredients

Zinc oxide 16%

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash and 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 withing a few days

Keep out of reach of children.

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

Directions

change wet and soiled diapers promptly
cleanse the diaper area and allow area to dry
apply cream liberally as often as necessary with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if quality seal is broken

Inactive ingredients

ricinus communis (castor) seed oil, hydrogenated castor oil, cocos nucifera (coconut) oil, beeswax, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) seed butter, persea gratissima (avocado) oil, aloe barbadensis leaf extract, gardenia taitensis flower extract, tocopherol, hydrogenated vegetable oil

Questions?

1-877-978-6286

Package Labeling:

Label2

BABY BUM DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69039-638
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69039-638-02	85 g in 1 TUBE; Type 0: Not a Combination Product	06/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/02/2021

Labeler - Sun Bum LLC (028642574)

Baby Bum Diaper Rash Cream