Label: NU SKIN TRI-PHASIC WHITE SYSTEM- avobenzone, octinoxate, and octisalate kit
- NDC Code(s): 62839-0273-1, 62839-2734-1
- Packager: NSE Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
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Directions
- Use in the morning after applying Tri-Phasic White® Essence. Apply liberally to face and neck.
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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.
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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
- Questions?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
NU SKIN TRI-PHASIC WHITE SYSTEM
avobenzone, octinoxate, and octisalate kitProduct 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 lotionProduct 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) liquidProduct 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 liquidProduct 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 liquidProduct 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 lotionProduct 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)
