BODYCOLOGY EXOTIC CHERRY KIT- exotic cherry 
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.

----------

Bodycology Exotic Cherry Kit

image of hang tag

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 a Poison Control Center immediately.

image of fragrance mist

Stop use and consult doctorif 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.

image of bodywash

Directions

-Wet hands with product.

-Briskly rub hands together until dry.

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

-Not recommended for infants.

image of bottle

Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf 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 butter

Bodycology

Moisturizing Hand Sanitizer

with Aloe Vera

kills 99% of germs without water

Exotic Cherry Blossom

30 mL 1 Fl Oz.

BODYCOLOGY  EXOTIC CHERRY KIT
exotic cherry kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-063
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-063-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 21 BOTTLE 177 mL
Part 31 BOTTLE 118 mL
Part 41 BOTTLE 70 g
Part 1 of 4
BODYCOLOGY  EXOTIC CHERRY HAND SANITIZER
ethyl alcohol gel
Product Information
Item Code (Source)NDC:51345-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 22.5 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:51345-064-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/30/2012
Part 2 of 4
BODYCOLOGY  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)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRHONEY (UNII: Y9H1V576FH)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
INGRLAURETH-10 (UNII: BD7AST04GA)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRSULISOBENZONE (UNII: 1W6L629B4K)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
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
Cosmetic06/30/2012
Part 3 of 4
BODYCOLOGY  FRAGRANCE MIST
other fragrance preparations
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALCOHOL (UNII: 3K9958V90M)  
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/15/2012
Part 4 of 4
BODYCOLOGY  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)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
INGR.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
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 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/07/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/03/2012
Labeler - Advanced Beauty Systems, Inc. (129986613)
Registrant - Advanced Beauty Systems, Inc. (129998613)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(51345-063, 51345-064)

Revised: 8/2012
Document Id: dde66f79-13bf-4681-9aee-f15062101b3f
Set id: 3803324c-40e5-4f54-b30c-0a3714a31306
Version: 3
Effective Time: 20120805
 
Advanced Beauty Systems, Inc.