TOASTED VANILLA SUGAR KIT BODYCOLOGY- alcohol 
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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Toasted vanilla sugar kit

Active Ingredient Purpose

Alcohol 75% Antiseptic


Uses For hand washing to decrease bacteria on the skin

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

Warnings

For external use only

Flammable. Keep away from flame or high heat.

When using this product

  • Avoid contact with eyes. If contact occurs flush eyes with water.
  • Avoid contact with Broken skin

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommeded for infants

Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf juice, Ultra marines (CI 77007)

tag


1 FL Oz / 30 mL

hand sanitzer

6 FL OZ / 177 mL

foaming body wash

4 FL OZ / 118 mL

fragrance

NET WT 2.47 OZ / 70 g

body butter

TOASTED VANILLA SUGAR KIT  BODYCOLOGY
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-109
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-109-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 21 BOTTLE 177 mL
Part 31 BOTTLE, SPRAY 118 mL
Part 41 JAR 70 g
Part 1 of 4
TOASTED VANILLA SUGAR HAND SANITIZER  BODYCOLOGY
alcohol liquid
Product Information
Item Code (Source)NDC:51345-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
GELATIN (UNII: 2G86QN327L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/25/2013
Part 2 of 4
TOASTED VANILLA SUGAR FOAMING BODY WASH 
body and hand (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
INGRLAURETH-10 (UNII: BD7AST04GA)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRHONEY (UNII: Y9H1V576FH)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSULISOBENZONE (UNII: 1W6L629B4K)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
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
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/25/2013
Part 3 of 4
TOASTED VANILLA SUGAR FRAGRANCE MIST 
other fragrance preparations
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSULISOBENZONE (UNII: 1W6L629B4K)  
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
1118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/25/2013
Part 4 of 4
TOASTED VANILLA SUGAR BODY BUTTER 
body and hand (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCARBOMER 940 (UNII: 4Q93RCW27E)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
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
170 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/25/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/25/2013
Labeler - Advanced Beauty Systems, Inc. (129986613)
Registrant - Advanced Beauty Systems, Inc. (129986613)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51345-109, 51345-110)

Revised: 7/2013
Document Id: 731cf7e3-ed44-452e-8cbd-f4f60751370a
Set id: d1fe1bdf-2755-4950-b884-2058f64607e6
Version: 2
Effective Time: 20130702
 
Advanced Beauty Systems, Inc.