BABYSPA SHEA BUTTER DIAPER- zinc oxide cream
EXPRO3 LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts
Active Ingredients Purpose
Zinc Oxide 12%......................Skin Protectant

Uses:

* Helps treat and prevent diaper rash and other minor skin irritations
* Seals out wetness

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
(U.S. -- 1-800-222-1222)

Directions:
Apply cream liberally, as often as necessary, with each diaper change for continuous protection

Warnings:
For external use only

Stop use and ask a doctor if:

* condition worsens
* symptoms last more than 7 days

shea butter (butyrospermum parkii), aloe barbadensis gel, cocoa (theobroma cacao) butter, beeswax, potato (solanium tuberosum) starch, cetearyl alcohol, grape (vitis vinifera) seed oil, kaolin, sesame (sesamum indicum) oil, titanium dioxide, phenoxyethanol, licorice (glycyrrhiza glabra) root extract, calendula officinalis seed oil, Unisooth EG-28 (water propyl gallate gallyl glucoside epigallocatechin gallatyl glucoside), glyceryl caprylate, olive (olea europaea) oil*, glycerin, chamomile (anthemis nobilis ) extract, benzoic acid, dehydroacetic acid, borage (borago officinalis) seed oil, evening primrose (oenothera biennis) oil, fragrance, lavender (lavandula angustifolia) extract.

BABYSPA SHEA BUTTER DIAPER
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42957-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
STARCH, POTATO (UNII: 8I089SAH3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GRAPE SEED OIL (UNII: 930MLC8XGG)
KAOLIN (UNII: 24H4NWX5CO)
SESAME OIL (UNII: QX10HYY4QV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
WATER (UNII: 059QF0KO0R)
PROPYL GALLATE (UNII: 8D4SNN7V92)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BORAGE OIL (UNII: F8XAG1755S)
OENOTHERA BIENNIS (UNII: 76UI55V071)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42957-001-01	100 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/18/2012

Labeler - EXPRO3 LLC (014904067)

Registrant - E.L. Erman Cosmetic Manufacturing Ltd (531894152)

Name	Address	ID/FEI	Business Operations
Establishment
E.L. Erman Cosmetic Manufacturing Ltd		531894152	manufacture(42957-001)