ULTRA REPAIR- shea butter cream 
ULAB

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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ACTIVE INGREDIENT

Active ingredients: SHEA BUTTER 4.0%

INACTIVE INGREDIENT

Inactive ingredients: Aqua (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOHEXADECANE, PEG-8 BEESWAX, MARIS AQUA (SEA WATER), MACADAMIA INTEGRIFOLIA SEED OIL, CETYL ALCOHOL, POLYACRYLAMIDE, PROPYLENE GLYCOL DIPELARGONATE, PHENOXYETHANOL, GLYCERYL STEARATE, PROPANEDIOL, C13-14 ISOPARAFFIN, HYDROXYACETOPHENONE, THEOBROMA GRANDIFLORUM SEED BUTTER, PROPYLENE GLYCOL, CETETH-20, TOCOPHERYL ACETATE, STEARETH-20, CENTELLA ASIATICA EXTRACT, LAURETH-7, GLYCERIN, PARFUM (FRAGRANCE), TOCOPHEROL, NYMPHAEA ALBA FLOWER EXTRACT, POTASSIUM SORBATE, CITRIC ACID, TROPOLONE, GARDENIA TAHITENSIS FLOWER EXTRACT, CUCURBITA PEPO (PUMPKIN) SEED EXTRACT, SODIUM HYDROXIDE, SODIUM BENZOATE

PURPOSE

Purpose: Moisturizing and soothing sensitized skin

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply morning and night

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply morning and night to face and neck after serum and ampoule

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ULTRA REPAIR 
shea butter cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER2.4 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71276-090-021 in 1 CARTON03/02/2017
1NDC:71276-090-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/02/2017
Labeler - ULAB (688976692)
Registrant - ULAB (688976692)
Establishment
NameAddressID/FEIBusiness Operations
ULAB688976692relabel(71276-090)
Establishment
NameAddressID/FEIBusiness Operations
U-LAB Switzerland AG485958743manufacture(71276-090)

Revised: 3/2017
Document Id: 08a33e6f-915f-4f1c-8cfc-91cba2d1352d
Set id: c21e1f4c-e670-4dd1-a681-2337d8383767
Version: 1
Effective Time: 20170322
 
ULAB