TOASTED VANILLA SUGAR KIT BODYCOLOGY- alcohol kit

Toasted Vanilla Sugar Kit by

Drug Labeling and Warnings

Toasted Vanilla Sugar Kit by is a Otc medication manufactured, distributed, or labeled by Advanced Beauty Systems, Inc., Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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)

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

TOASTED VANILLA SUGAR KIT  BODYCOLOGY
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51345-109

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-109-01	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30 mL
Part 2	1 BOTTLE	177 mL
Part 3	1 BOTTLE, SPRAY	118 mL
Part 4	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2013

Part 2 of 4

TOASTED VANILLA SUGAR FOAMING BODY WASH 
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	COCO MONOETHANOLAMIDE (UNII: C80684146D)
INGR	LAURETH-10 (UNII: BD7AST04GA)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/25/2013

Part 3 of 4

TOASTED VANILLA SUGAR FRAGRANCE MIST 
other fragrance preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/25/2013

Part 4 of 4

TOASTED VANILLA SUGAR BODY BUTTER 
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	COCOA BUTTER (UNII: 512OYT1CRR)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CARBOMER 940 (UNII: 4Q93RCW27E)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/25/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2013

Labeler - Advanced Beauty Systems, Inc. (129986613)

Registrant - Advanced Beauty Systems, Inc. (129986613)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51345-109, 51345-110)