BABY BUM DIAPER RASH- zinc oxide cream

Baby Bum Diaper Rash by

Drug Labeling and Warnings

Baby Bum Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

Call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

BABY BUM DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-279
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-279-00	1 in 1 BOX	01/01/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2018

Labeler - Sun Bum LLC (028642574)