Bodycology Toasted Vanilla Sugar Kit

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Drug Facts

Active ingredient Purpose

Ethyl Alcohol 75% Antiseptic

Uses To decrease bacteria on the skin.

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

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.

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Directions

-Wet hands with product.

-Briskly rub hands together until dry.

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

-Not recommended for infants.

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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

Moisturiozing Hand Sanitizer

with Aloe Vera

kills 99% of bacteria without water

30 mL 1 Fl Oz.

BODYCOLOGY TOASTED VANILLA SUGAR KIT
toasted vanilla sugar kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51345-065

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51345-065-01	1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	30 mL
Part 2	1 BOTTLE	177 mL
Part 3	1 BOTTLE	118 mL
Part 4	1 BOTTLE	70 g

Part 1 of 4

BODYCOLOGY TOASTED VANILLA SUGAR HAND SANITIZER
ethyl alcohol gel

Product Information
Item Code (Source)	NDC:51345-066
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.5 mL in 22.5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51345-066-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/30/2012

Part 2 of 4

BODYCOLOGY FOAMING BODY WASH
body and hand (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	COCO MONOETHANOLAMIDE (UNII: C80684146D)
INGR	LAURETH-10 (UNII: BD7AST04GA)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		177 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		06/30/2012

Part 3 of 4

BODYCOLOGY FRAGRANCE MIST
other fragrance preparations

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		07/15/2012

Part 4 of 4

BODYCOLOGY BODY BUTTER
body and hand (excluding shaving preparations)

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	COCOA BUTTER (UNII: 512OYT1CRR)
INGR	.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		70 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		08/07/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/03/2012

Labeler - Advanced Beauty Systems, Inc. (129986613)

Registrant - Advanced Beauty Systems, Inc. (129998613)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51345-065, 51345-066)