NU SKIN TRI-PHASIC WHITE SYSTEM- avobenzone, octinoxate, and octisalate kit

Nu Skin Tri-Phasic White System by

Drug Labeling and Warnings

Nu Skin Tri-Phasic White System by is a Otc medication manufactured, distributed, or labeled by NSE Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Nu Skin® Tri-Phasic White® Day Milk Lotion Broad Spectrum SPF 15

Drug Facts

Active Ingredient

Avobenzone (2.4%), Octinoxate (7.4%), Octisalate (3.0%)

Purpose

Sunscreen

Use

• Helps prevent sunburn. Higher SPF gives more sunburn protection.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only.

• Do not use on damaged or broken skin.

• Stop use and ask a doctor if rash occurs.

• When using this product, keep out of eyes. Rinse with water to remove.

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use in the morning after applying Tri-Phasic White® Essence. Apply liberally to face and neck.
• Sunprotection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.–2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor.

Inactive Ingredients

Water (Aqua), Cyclomethicone, Butylene Glycol, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Octyldodecyl Neopentanoate, Glycerin, Squalane, Hexapeptide-2, Caprylic/ Capric Triglyceride, Phenyl Trimethicone, Tocopheryl Acetate, Allantoin, Phospholipids, Xanthan Gum, Dimethiconol, Dextran, Polyphosphorylcholine Glycol Acrylate, Polysorbate 80, PEG-8, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Aminomethyl Propanol, Disodium EDTA, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid.

Other Information

• Protect this product from excessive heat and direct sun.

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - Kit Carton

NU SKIN

Tri-Phasic White®

SYSTEM

INGREDIENTS AND APPEARANCE

NU SKIN TRI-PHASIC WHITE SYSTEM 
avobenzone, octinoxate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-2734

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-2734-1	1 in 1 CARTON; Type 0: Not a Combination Product	04/01/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	75 mL
Part 2	1 TUBE	100 mL
Part 3	1 BOTTLE, PLASTIC	125 mL
Part 4	1 BOTTLE, PUMP	30 mL
Part 5	1 JAR	30 mL

Part 1 of 5

NU SKIN TRI-PHASIC WHITE DAY MILK BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate lotion

Product Information
Item Code (Source)	NDC: 62839-0273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	24 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	74 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cyclomethicone (UNII: NMQ347994Z)
Butylene Glycol (UNII: 3XUS85K0RA)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Squalane (UNII: GW89575KF9)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
Glycerin (UNII: PDC6A3C0OX)
Allantoin (UNII: 344S277G0Z)
Edetate Disodium (UNII: 7FLD91C86K)
Polysorbate 60 (UNII: CAL22UVI4M)
Methylparaben (UNII: A2I8C7HI9T)
Benzoic Acid (UNII: 8SKN0B0MIM)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aminomethylpropanol (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-0273-1	75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2013

Part 2 of 5

NU SKIN TRI-PHASIC WHITE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Cocoyl Isethionate (UNII: 518XTE8493)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	Diglycerin (UNII: 3YC120743U)
INGR	Glycol Stearate (UNII: 0324G66D0E)
INGR	Safflower Oil (UNII: 65UEH262IS)
INGR	Creatinine (UNII: AYI8EX34EU)
INGR	Laureth-4 (UNII: 6HQ855798J)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Edetate Disodium (UNII: 7FLD91C86K)
INGR	Propylparaben (UNII: Z8IX2SC1OH)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Pinus Tabuliformis Bark (UNII: 3G75L8C3RU)
INGR	Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
INGR	Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/01/2013

Part 3 of 5

NU SKIN TRI-PHASIC WHITE TONER 
other skin care preparations liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Deanol (UNII: 2N6K9DRA24)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Urea (UNII: 8W8T17847W)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Glucosamine Hydrochloride (UNII: 750W5330FY)
INGR	Carnosine (UNII: 8HO6PVN24W)
INGR	Yeast, Unspecified (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/01/2013

Part 4 of 5

NU SKIN TRI-PHASIC WHITE ESSENCE 
other skin care preparations liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
INGR	Squalane (UNII: GW89575KF9)
INGR	Wheat Germ (UNII: YR3G369F5A)
INGR	Lemon Peel (UNII: 72O054U628)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Polysorbate 60 (UNII: CAL22UVI4M)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Mentha Piperita Leaf (UNII: A389O33LX6)
INGR	Ethylparaben (UNII: 14255EXE39)
INGR	Edetate Disodium (UNII: 7FLD91C86K)
INGR	Phytosphingosine (UNII: GIN46U9Q2Q)
INGR	Vitis Vinifera Seed (UNII: C34U15ICXA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/01/2013

Part 5 of 5

NU SKIN TRI-PHASIC WHITE NIGHT 
night lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Ethylhexyl Palmitate (UNII: 2865993309)
INGR	Medium-Chain Triglycerides (UNII: C9H2L21V7U)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Docosanol (UNII: 9G1OE216XY)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Panthenol (UNII: WV9CM0O67Z)
INGR	PEG-75 Stearate (UNII: OT38R0N74H)
INGR	Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Aminomethylpropanol (UNII: LU49E6626Q)
INGR	Ceteth-20 (UNII: I835H2IHHX)
INGR	Steareth-20 (UNII: L0Q8IK9E08)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	C12-13 Pareth-23 (UNII: J1WW1510L4)
INGR	Tetrahydropiperine (UNII: 8904DO502T)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)
INGR	Diacetyl Boldine (UNII: 37727Z7M0I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2013

Labeler - NSE Products, Inc. (803486393)