BODYCOLOGY TOASTED VANILLA KIT- toasted vanilla 
Advanced Beauty Systems, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bodycology Toasted Vanilla sugar 2 kit

Drug Facts

Active ingredient Purpose

Ethyl Alcohol 75% Antiseptic

Uses To decrease bacteria on the skin.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact aPoisonControlCenter immediately.

Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.

Warnings

For external use only.

FLAMMABLE. Keep away from heat and flame.

When using this product

Avoid contact with eyes. If contact occurs, flush eyes with water.

Avoid contact with broken skin.

Directions

-Wet hands with product.

-Briskly rub hands together until dry.

-For children under 6, use only under adult supervision.

-Not recommended for infants.

Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007).

May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200).

image of body cream artimage of bottle artimage of backer art

Moisturizing Hand Sanitizer

with Aloe Vera

kills 99% of germs without water

Toasted Vanilla

30 mL 1 Fl Oz

BODYCOLOGY  TOASTED VANILLA KIT
toasted vanilla kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-057
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-057-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE 30 mL
Part 21 BOTTLE 30 g
Part 1 of 2
BODYCOLOGY  TOASTED VANILLA SUGAR HAND SANITIZER
ethyl alcohol gel
Product Information
Item Code (Source)NDC:51345-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
GELATIN (UNII: 2G86QN327L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-058-0130 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/30/2012
Part 2 of 2
BODYCOLOGY  NOURISHING BODY
body and hand (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRSULISOBENZONE (UNII: 1W6L629B4K)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGR2,4-DIAMINOPHENOXYETHANOL HYDROCHLORIDE (UNII: Z5Y843J6KQ)  
INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/30/2012
Labeler - Advanced Beauty Systems, Inc. (129986613)
Registrant - Advanced Beauty Systems, Inc. (129986613)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51345-057, 51345-058)

Revised: 8/2012
Document Id: 81a63de1-72c5-4b34-b677-b535b14f03b6
Set id: 35fdc46e-8ede-4b1d-9952-8fc4bb642d50
Version: 6
Effective Time: 20120820
 
Advanced Beauty Systems, Inc.