XOXO KIT BODYCOLOGY- alcohol kit

XOXO Kit by

Drug Labeling and Warnings

XOXO Kit by is a Otc medication manufactured, distributed, or labeled by Advanced Beauty Systems, Inc., 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)

May Contain: Red 4 (CI 14700), Yellow 5 (CI 19140), Blue 1 (CI 42090), Red 33 (CI 17200).

PRINCIPAL DISPLAY PANEL

1 FL OZ / 30 mL

hand sanitizer

6 FL OZ / 177 mL

foaming body wash

4 FL OZ / 118 mL

fragrance mist

NET WT 2.47 OZ / 70 g

body butter

INGREDIENTS AND APPEARANCE

XOXO KIT  BODYCOLOGY
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51345-111

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-111-01	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

XOXO HAND SANITIZER 
alcohol liquid

Product Information
Item Code (Source)	NDC: 51345-112
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-112-01	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	06/27/2013

Part 2 of 4

XOXO 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		06/27/2013

Part 3 of 4

XOXO 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		06/27/2013

Part 4 of 4

XOXO 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		06/27/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/27/2013

Labeler - Advanced Beauty Systems, Inc. (129986613)

Registrant - Advanced Beauty Systems, Inc. (129986613)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51345-111, 51345-112)